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Monoclonal Antibodies

Rituximab + Stem Cell Transplant for Mantle Cell Lymphoma

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.

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.

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.

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.

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 2022 Phase 3 trial • 665 Patients • NCT00567567

84%

58300-Neutrophil count decreased

70%

65800-Platelet count decreased

20%

43100-Hypokalemia

18%

44800-Infections and infestations - Other specify

18%

33300-Febrile neutropenia

17%

88500-White blood cell decreased

13%

13200-Anemia

55600-Mucositis oral

42700-Hypocalcemia

13500-Anorexia

11600-Alanine aminotransferase increased

41400-Hyperglycemia

15000-Aspartate aminotransferase increased

43300-Hyponatremia

73700-Sepsis

53700-Lymphocyte count decreased

25700-Diarrhea

65900-Pleural effusion

57600-Nausea

37500-GGT increased

41600-Hyperkalemia

10300-Abdominal pain

20500-Catheter related infection

59700-Oral pain

38900-Hearing impaired

43900-Hypoxia

17200-Blood and lymphatic system disorders - Other specify

14900-Ascites

75700-Small intestinal obstruction

87900-Vomiting

43600-Hypotension

45800-INR increased

34000-Fibrinogen decreased

23000-Confusion

42600-Hypoalbuminemia

69700-Rash maculo-papular

71500-Respiratory failure

73900-Serum amylase increased

26600-Duodenal obstruction

66300-Pneumonitis

58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify

56600-Myelitis

75600-Small intestinal mucositis

66800-Postoperative hemorrhage

43500-Hypophosphatemia

37300-Generalized muscle weakness

81200-Treatment related secondary malignancy

31200-Esophagitis

83100-Urinary tract infection

24100-Creatinine increased

11100-Acute kidney injury

62600-Pelvic pain

65300-Pharyngolaryngeal pain

31900-Eye disorders - Other specify

10900-Activated partial thromboplastin time prolonged

11800-Alkaline phosphatase increased

42500-Hyperuricemia

17400-Blood bilirubin increased

63100-Pericardial effusion

72700-Right ventricular dysfunction

37200-General disorders and administration site conditions - Other specify

40000-Hepatic failure

88200-Weight gain

41300-Hypercalcemia

54900-Metabolism and nutrition disorders - Other specify

71000-Renal and urinary disorders - Other specify

69000-Pulmonary hypertension

20100-Cardiac disorders - Other specify

22100-Colitis

44200-Ileal obstruction

81900-Typhlitis

33900-Fever

35500-Gallbladder pain

40600-Hepatobiliary disorders - Other specify

66500-Portal hypertension

12000-Allergic reaction

13100-Anaphylaxis

44700-Immune system disorders - Other specify

13400-Anorectal infection

25600-Device related infection

29500-Enterocolitis infectious

53100-Lung infection

62500-Pelvic infection

75200-Skin infection

82300-Upper respiratory infection

14500-Arterial injury

15300-Ataxia

38800-Headache

63900-Peripheral motor neuropathy

11300-Adult respiratory distress syndrome

29700-Epistaxis

78100-Stridor

68400-Pruritus

51700-Left ventricular systolic dysfunction

27800-Dyspnea

58100-Nervous system disorders - Other specify

29000-Encephalopathy

42100-Hypertension

24700-Dehydration

43200-Hypomagnesemia

31800-Extrapyramidal disorder

52600-Lipase increased

10700-Acidosis

100%

80%

60%

40%

20%

Study treatment Arm

Tandem HST (CEM), Randomly Assigned

Single HST (CEM)

Not Assigned

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

Positron Emission Tomography

2011

Completed Phase 2

~2200

Bone Marrow Biopsy

2021

Completed Phase 3

~230