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Monoclonal Antibodies

Rituximab + Stem Cell Transplant for Mantle Cell Lymphoma

Phase 3
Recruiting
Led By Timothy 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

Study 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.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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) in MCL patients in MRD-negative first remission who undergo auto-HCT followed by rituximab vs. maintenance rituximab alone
Secondary outcome measures
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
MRD status in MCL patients who were MRD-positive prior to auto-HCT
Hematocrit procedure
+3 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
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
57600-Nausea
3%
65900-Pleural effusion
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
23000-Confusion
1%
34000-Fibrinogen decreased
1%
73900-Serum amylase increased
1%
26600-Duodenal obstruction
1%
71500-Respiratory failure
1%
42600-Hypoalbuminemia
1%
45800-INR increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
66300-Pneumonitis
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
69700-Rash maculo-papular
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group II (rituximab alone)Experimental Treatment2 Interventions
Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.
Group II: Group I (auto-HCT, rituximab)Experimental Treatment3 Interventions
Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab IV once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,926,946 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,233 Total Patients Enrolled
Timothy FenskePrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03267433 — Phase 3
Mantle Cell Lymphoma Research Study Groups: Group II (rituximab alone), Group I (auto-HCT, rituximab)
Mantle Cell Lymphoma Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT03267433 — Phase 3
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03267433 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project have more than one location in this state?

"There are many hospitals participating in this trial, but to list a few; Saint Louis University Hospital (Saint Louis, Missouri), The James Graham Brown Cancer Center at University of Louisville (Louisville, Kentucky), and Marshfield Medical Center-Rice Lake (Rice Lake, Wisconsin) are just some of the 100 other locations."

Answered by AI

Could you explain what Autologous Hematopoietic Stem Cell Transplantation is commonly used to treat?

"Autologous Hematopoietic Stem Cell Transplantation is a treatment that uses the patient's own stem cells. It is most often used to treat dlbcl, but can also be used for other conditions such as b-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI

Does Autologous Hematopoietic Stem Cell Transplantation have a lot of risks?

"There is prior clinical data supporting Autologous Hematopoietic Stem Cell Transplantation's safety, so it received a score of 3."

Answered by AI

Are people who are 30 years or older being recruited for this clinical trial?

"The age requirements for this trial are that patients must be over 18 years old and cannot be above the age of 70."

Answered by AI

How many patients are approved to enroll in this clinical trial?

"Accurate, the listing on clinicaltrials.gov does show that this trial is actively recruiting patients. The posting date was 8/29/2017 with the most recent edit on 12/22/2021. 100 medical sites are looking to enroll a total of 689 individuals for this research project."

Answered by AI

What are some other research examples of Autologous Hematopoietic Stem Cell Transplantation?

"The first study into Autologous Hematopoietic Stem Cell Transplantation was completed in 1993 at the National Institutes of Health Clinical Center. As of now, 1363 trials have been completed with 420 more presently recruiting patients. A large number of these active studies are based out of Saint Louis, Missouri."

Answered by AI

Are people with the required medical conditions able to participate in this trial at this time?

"This clinical trial, which was originally posted on 8/29/2017 and most recently edited on 12/22/2021, is currently recruiting candidates."

Answered by AI

If I wanted to, could I be a subject in this experiment?

"689 people, ranging in age from 18 to 70 and currently diagnosed with mantle cell lymphoma (mcl) are being enrolled in this study. To be eligible, potential patients must meet the following conditions: They should be considered a willing candidate for auto-HCT by their enrolling physician and have the potential to respond well to treatment; For those who have completed induction therapy, restaging evaluation needs to show that they are in partial (PR) or complete response (CR); Patients who have been registered post-induction with evidence of clinical disease progression are not allowed; Those who have received or completed induction therapy within 60 days prior"

Answered by AI
~221 spots leftby Jan 2027