Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

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Results 1 - 10 of 56

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of Intermediate Fit Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance
Objective:

Dual Primary Objectives:

To compare progression-free survival (PFS) in frail or selected intermediate fit
Newly Diagnosed Multiple Myeloma (NDMM) participants treated with VRd-Lite
induction followed by Lenalidomide maintenance (Arm 1) versus DRd induction
followed by Lenalidomide maintenance (Arm 2).

To compare overall survival (OS) in frail or selected intermediate fit NDMM
participants treated with VRd-Lite induction followed by lenalidomide maintenance
(Arm 1) versus DRd induction followed by lenalidomide and daratumumab and
hyaluronidase-fihj maintenance (Arm 3).

Secondary Objectives

To compare PFS in Arm 1 versus Arm 3

To compare OS in Arm 1 versus Arm 2.

To compare OS in Arm 2 versus Arm 3, contingent upon significant results from both dual primary endpoints in favor of the respective experimental arms.

To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.

To assess the safety of Arm 1 with the safety of Arm 2 and Arm 3.

To explore veinous and arterial thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.

To describe median time to response (CR or better per IMWG criteria, VGPR or better per IMWG criteria, PR or better per IMWG criteria) on the three study arms.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Cole, Craig
Karmanos Trial ID:
S2209
Age Group:
Adult
Phase:
Phase III
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A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis
Objective:

Primary Objective:

To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.

Secondary Objectives

To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.

To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.

To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.

To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.

To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Kin, Andrew
Karmanos Trial ID:
S2213
Age Group:
Adult
Phase:
Phase III
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A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
Objective:

Primary Objectives:

To compare the progression-free survival in participants with relapsed/refractory
large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD)
or partial remission (PR) on first imaging response by central review (day +30
PET/CT scan) after commercial CD19 CAR T-cell therapy who are randomized to
receive each consolidation therapy versus those that receive no consolidation
therapy (i.e. control). Specifically, to compare the PFS of 1) mosunetuzumab
consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no
consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation

Secondary Objectives:

To compare overall survival (OS) in participants randomized to each consolidation
treatment arm versus control.

To compare the complete remission (CR) conversion rate up to one year in
participants randomized to each consolidation arm versus control.

To evaluate the treatment-related adverse events in participants randomized to
each consolidation arm.

To evaluate the association between total metabolic tumor volume (TMTV), SUV
max, and sum product (SPD) of diameters by PET-CT at first imaging response
with complete remission conversion up to one year in participants randomized to
each consolidation arm as well as those randomized to control.

To evaluate the overall response rate (ORR), CR rate, PFS, and OS of participants
randomized to Arm 4 (observation) who have lymphoma progression within 12
months of CAR T-cell infusion and subsequently ‘cross-over' to receive treatment
with mosunetuzumab + polatuzumab vedotin.

To estimate overall survival for all patients registered to this study.

To assess the difference in overall survival between participants who achieved CR
at first imaging (day +30) versus. those who did not achieve CR at first imaging.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
S2114
Age Group:
Adult
Phase:
Phase II
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Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Objective:
Primary Objective:

To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.

Secondary Objectives of First Randomization:

To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.

To compare progression-free survival (PFS) between the study arms in this patient population.

To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.

To compare toxicities and tolerability of long term therapy between the study arms.

Objectives of Second Randomization:

To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.

To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Kin, Andrew
Karmanos Trial ID:
S1803
Age Group:
Adult
Phase:
Phase III
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A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease
Objective:

Primary Objective:

The primary objective of this study is to assess efficacy of CYP-001 in subjects with HRaGvHD by Overall Response Rate (ORR) at Day 28.

Secondary Objectives:

To assess additional responses and long-term efficacy outcomes

To assess Overall Survival (OS)

To assess Event-Free survival (EFS)

To assess Non-Relapse Mortality (NRM)

To assess Failure Free Survival

To assess the incidence of Malignancy Relapse/Progression (MR)

To measure the incidence of chronic GvHD

To assess the cumulative steroid dose until Day 100

To evaluate changes in Subject Reported Outcomes

To evaluate the safety and tolerability of CYP-001 in subjects with SR-aGvHD
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
2024-027
Age Group:
Adult
Phase:
Phase II
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A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkin's Lymphoma
Objective:

Primary Objectives:

To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule

Secondary Objectives:

To characterize the pharmacokinetic profile of ARV-393 in plasma

To assess the preliminary anti-tumor activity of ARV-393
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2024-047
Age Group:
Adult
Phase:
Phase I
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A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of KQB198 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hematologic Malignancies
Objective:

Primary Objective:

Part 1: To determine the safety, tolerability, and RP2D of KQB198 as monotherapy and in combination with dasatinib

Part 2, Cohort A: To evaluate the efficacy of KQB198 in combination with dasatinib and determine the OBD

Part 2, Cohort B: To evaluate the efficacy of KQB198 monotherapy and determine the OBD

Secondary Objective:

Part 1: To evaluate the efficacy of KQB198 as monotherapy and in combination with dasatinib

Part 2, Cohorts A and B: To evaluate the efficacy of KQB198 monotherapy and in combination with dasatinib

All Parts: To evaluate the safety and tolerability of KQB198 as monotherapy and in combination with dasatinib

All Parts: To evaluate the plasma pharmacokinetics (PK) of KQB198 alone or KQB198 and dasatinib when administered in combination
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
2024-055
Age Group:
Adult
Phase:
Phase I
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A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma
Objective:

Primary Objective (Monotherapy Escalation):

To characterize the safety and tolerability of OPN-6602 in order to identify the RP2D

Secondary Objectives (Monotherapy Escalation):

To evaluate preliminary antitumor activity of OPN-6602

To evaluate the PK of OPN-6602

Primary Objective (Combination Escalation):

To characterize the safety and tolerability of OPN-6602 plus dexamethasone in order to identify the RP2D

Secondary Objectives (Combination Escalation):

To evaluate preliminary antitumor activity of OPN-6602 plus dexamethasone

To evaluate the PK of OPN-6602 when in combination with dexamethasone

Primary Objective (Expansion Monotherapy or Combination):

To evaluate preliminary antitumor activity of OPN-6602 when administered in combination with or without dexamethasone

Secondary Objectives (Expansion Monotherapy or Combination):

To further evaluate preliminary antitumor activity of OPN-6602 when administered in combination with or without dexamethasone

To evaluate the PK of OPN-6602 when administered in combination with or without Dexamethasone
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Zonder, Jeffrey
Karmanos Trial ID:
2024-056
Age Group:
Adult
Phase:
Phase I
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A Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Objective:

Primary Objectives:

To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI + chemotherapy.

Secondary Objectives:

To compare the rate of MRD negativity for patients treated with chemotherapy vs blinatumomab at the end of first induction (week 15).

To evaluate the rate of the MRD negativity by treatment arm for those patients MRD positive after the first induction and administered of second induction.

To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab. (Events include failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission).

To assess the toxicities of blinatumomab+TKI and steroids + TKI + chemotherapy in this patient population.

To assess the toxicities of the chemotherapy regimen in this patient population.

To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab+TKI only.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
EA9181
Age Group:
Adult
Phase:
Phase III
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A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
Objective:

Primary Objective:

To compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without auto- HCT).

Secondary Objectives:

To compare progression-free survival in MCL patients in MRDnegative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.

To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.

To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
EA4151/BMTCTN1601
Age Group:
Adult
Phase:
Phase III
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