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Monoclonal Antibodies

Rituximab + Stem Cell Transplant for Mantle Cell Lymphoma

Las Vegas, NV

Phase 3

Waitlist Available

Led By Timothy S Fenske

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have received at least four (4) cycles of induction therapy

Women must not be pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if rituximab works better with or without stem cell transplant for mantle cell lymphoma in patients who are in first complete remission.

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Who is the study for?

This trial is for patients with mantle cell lymphoma in first complete remission and no minimal residual disease. Candidates must have completed certain therapies, be eligible for stem cell transplant, and not have CNS involvement by the lymphoma. HIV+ individuals can join if they meet specific health criteria. Pregnant or breastfeeding women are excluded, as well as those with recent other cancers or without a confirmed diagnosis.Check my eligibility

What is being tested?

The study compares rituximab effectiveness after a stem cell transplant versus rituximab alone in treating mantle cell lymphoma that's in remission. It looks at how these treatments affect cancer cells' growth and spread, involving chemotherapy to prepare for the patient's own collected stem cells to be transplanted back into their body.See study design

What are the potential side effects?

Rituximab may cause infusion reactions, infections due to low blood counts, fatigue, and allergic reactions. Stem cell transplantation can lead to complications like graft-versus-host disease (where transplanted immune cells attack your body), infection risks from low immunity post-transplant, organ damage from high-dose chemo before transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have completed at least 4 cycles of initial cancer treatment.

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I am not pregnant or breastfeeding.

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My scans show my cancer has responded well to treatment.

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I have a preserved tissue sample from my initial diagnosis for testing.

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My lymphoma is confirmed to be mantle cell type with specific genetic markers.

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My lymphoma has not spread to my brain or spinal cord.

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I can take care of myself and am up and about more than half of my waking hours.

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I meet the health requirements for a stem cell transplant.

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My cancer responded to initial treatment without showing signs of getting worse.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS) in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative complete remission (CR) who undergo auto-hematopoietic stem cell transplant (HCT) followed by rituximab versus (vs.) maintenance rituximab alone

Secondary study objectives

Incidence of adverse events

MRD status in MCL patients who were MRD-positive prior to auto-HCT

OS in MRD-negative PR patients, MRD-positive CR patients, MRD-positive PR patients, and MRD-indeterminate patients who undergo auto-HCT followed by rituximab

+2 more

Side effects data

From 2024 Phase 3 trial • 60 Patients • NCT00554788

50%

Febrile neutropenia

33%

Infections and infestations - Other, specify

33%

Anorexia

28%

Mucositis oral

22%

Vomiting

17%

Hypokalemia

17%

Alanine aminotransferase increased

17%

Diarrhea

11%

Enterocolitis infectious

11%

Aspartate aminotransferase increased

11%

Hypotension

11%

Nausea

11%

Dehydration

Enterocolitis

Esophagitis

Pain

Gastric hemorrhage

Sepsis

Rectal pain

Acute kidney injury

Abdominal pain

Hearing impaired

Hypoxia

Oral pain

Skin infection

Upper respiratory infection

Hypocalcemia

Lower gastrointestinal hemorrhage

Pharyngeal mucositis

GGT increased

Hypomagnesemia

Hypertension

Sinus tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Stage 4a Patients

Stage 2/3 Patients

Stage 4b Patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (rituximab)Experimental Treatment7 Interventions

Patients receive standard of care induction chemotherapy. Beginning 40-180 days after completion of chemotherapy, patients receive rituximab or rituximab and hyaluronidase human or any approved rituximab biosimilar at the approved dose, as in Group I. Patients undergo PET, CT or PET/CT throughout the study. Patients may undergo blood sample collection during screening and on study. Patients also may undergo bone marrow biopsy and aspirate during screening.

Group II: Group I (auto-HCT, rituximab)Experimental Treatment8 Interventions

Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 100-140 days after transplant, patients receive rituximab IV or rituximab and hyaluronidase human SC or any approved rituximab biosimilar at the approved dose once every 8 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT or PET/CT throughout the study. Patients may undergo blood sample collection during screening and on study. Patients also may undergo bone marrow biopsy and aspirate during screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspirate

2015

Completed Phase 3

~40

Bone Marrow Biopsy

2021

Completed Phase 3

~270