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Alkylating agents

Autologous stem cell transplant for Mantle Cell Lymphoma

Phase 1
Waitlist Available
Led By Brad S Kahl, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible for autologous stem cell transplantation.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it is more effective than the standard treatment for leukemia.

Eligible Conditions
  • Mantle Cell Lymphoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Stem cell mobilization success rate
Secondary outcome measures
Overall response rate
Overall survival (OS)
Pre-transplant complete response rate (CRR)
+2 more

Side effects data

From 2016 Phase 2 trial • 30 Patients • NCT01182415
7%
Anemia
7%
Platelet count decreased
3%
Encephalopathy
3%
Alanine aminotransferase increased
3%
Investigations - Other, specify
3%
Aspartate aminotransferase increased
3%
Febrile neutropenia
3%
Mucositis oral
3%
Depression
3%
Gait disturbance
3%
Lymphocyte count decreased
3%
Lung infection
3%
Hypertension
3%
Pneumothorax
3%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
High-dose Chemotherapy With Autologous Stem Cell Transplant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bendamustine, Rituximab, CytarabineExperimental Treatment7 Interventions
Bendamustine on Days 1 and 2 of Cycles 1, 3, and 5. In Cycle 1, rituximab on Day 1 or 2 at the investigator's discretion. Given on Day 1 of Cycles 2 through 6. On Days 1 and 2 of Cycles 2, 4, and 6, cytarabine will be administered every 12 hours for a total of 4 doses. Growth factor will be administered subcutaneously within 72 hours of completion of each even-numbered cycles of chemotherapy. Leukapheresis will begin when the total WBC ≥ 5000/ μL and continue daily until collection of ≥ 2x106 CD34+ cells/kg (with a maximum of 5 courses of apheresis). Standard of care peripheral blood autologous stem cell harvest will proceed per institutional guidelines and begin during Cycle 6 following rituximab and cytarabine therapy, when the total WBC ≥ 5000/ μL. Collection will continue on a daily basis until collection of ≥ 2x106 CD34+ cells/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
2000
Completed Phase 3
~3670
Rituximab
1999
Completed Phase 4
~1880
Bendamustine
2015
Completed Phase 3
~2950
Cytarabine
2016
Completed Phase 3
~3310
Leukapheresis
2010
Completed Phase 2
~640
Pegfilgrastim
2013
Completed Phase 3
~4410
Autologous stem cell transplant
2010
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,070 Total Patients Enrolled
Brad S Kahl, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02728531 — Phase 1
Mantle Cell Lymphoma Research Study Groups: Bendamustine, Rituximab, Cytarabine
Mantle Cell Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT02728531 — Phase 1
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02728531 — Phase 1

Frequently Asked Questions

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

What other research has been conducted on Autologous stem cell transplantation?

"Currently, 750 clinical trials are underway researching Autologous stem cell transplant. Of those studies in progress, 176 have reached Phase 3 status and are disseminated across 26656 sites - the majority of which reside in Bethesda, Maryland."

Answered by AI

What diseases has Autologous stem cell transplant proven beneficial in managing?

"Autologous stem cell transplant has been used to treat a variety of illnesses, including contagions and hematological malignancies like dlbcl, meningeal leukemia, or mobilization of hematopoietic cells."

Answered by AI

To what extent is Autologous stem cell transplant potentially hazardous to individuals?

"Our team at Power has rated Autologous stem cell transplant a 1 on the safety scale due to its Phase 1 trial status, indicating minimal prior data supporting both efficacy and protection."

Answered by AI

In what magnitude is the pool of participants enrolled in this clinical experiment?

"This study has already closed for recruitment; the initial posting date was April 18th 2016 and the last update came on May 23rd 2022. For those searching additional clinical trials, there are currently 1721 open studies concerning lymphoma and 750 medical studies regarding autologous stem cell transplantation that are still admitting patients."

Answered by AI

Is there an opportunity to take part in this medical research?

"This experiment seeks 18 individuals ranging from majority age to 65, all of whom possess lymphoma. All candidates must additionally meet the following requirements: Eighteen years old or older and not beyond their sixty-fifth birthday; An ECOG performance status no more than 2; Platelet count at least one hundred thousand/mcl unless otherwise deemed by the attending physician as a consequence of splenomegaly or bone marrow infiltration."

Answered by AI

Are there any recruitment opportunities available for this trial?

"Clinicaltrials.gov does not list this medical trial as actively enrolling participants at the present moment, despite its posting on April 18th 2016 and last update of May 23rd 2022. However, there are 2,471 other trials that remain open for patient recruitment."

Answered by AI

Does this research initiative admit elderly participants?

"This trial is limited to those aged 18-65. However, there are 478 other clinical trials for minors and 2160 studies available for older individuals."

Answered by AI
~2 spots leftby Mar 2025