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Stem Cell Transplant + Chemotherapy for Lymphoma

Phase 2
Waitlist Available
Led By Matthew Mei, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initial treatment to the last disease assessment, up to two years
Awards & highlights

Study Summary

This trial is studying two drugs given together with other drugs before and after a stem cell transplant. The purpose is to see if this can help control B-cell non-Hodgkin lymphoma.

Who is the study for?
This trial is for patients under 75 with B-cell non-Hodgkin lymphoma who've had a response to prior therapy or never responded, including those without active central nervous system disease. Donors must be HLA-matched, healthy, and willing to undergo procedures for stem cell collection. Exclusions include previous radioimmunotherapy, certain other cancers within the last 5 years (except some skin cancers), active hepatitis B/C infection, and high peripheral lymphocyte counts in specific cases.Check my eligibility
What is being tested?
The study tests a combination of monoclonal antibody therapy (rituximab), radioimmunotherapy (indium In 111 ibritumomab tiuxetan and yttrium Y 90 ibritumomab tiuxetan), chemotherapy drugs (fludarabine phosphate and melphalan), followed by allogeneic hematopoietic stem cell transplantation from donors. It also includes tacrolimus and sirolimus administration to prevent graft-versus-host disease.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune suppression such as infections, complications from bone marrow transplant like graft-versus-host disease, organ inflammation due to monoclonal antibodies or radioimmunotherapy agents used in treatment. Chemotherapeutic agents can cause nausea, fatigue, hair loss, blood count changes leading to increased bleeding or infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initial treatment to the last disease assessment, up to two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initial treatment to the last disease assessment, up to two 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
Relapse/Progression Rate at Two Years
Secondary outcome measures
Overall Survival at Two Years
Progression-free Survival at Two Years

Side effects data

From 2014 Phase 3 trial • 25 Patients • NCT00322101
55%
Mucositis
45%
Infection
18%
severe diarrhea due to gut GVHD
9%
Thrombotic Microangiopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Myeloablative Regimen)
Arm I (Nonmyeloablative Regimen)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemo, monoclonal antibody therapy, transplant)Experimental Treatment9 Interventions
REDUCED-INTENSITY CONDITIONING: Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. STEM CELL TRANSPLANTATION: Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
indium In 111 ibritumomab tiuxetan
2003
Completed Phase 2
~160
yttrium Y 90 ibritumomab tiuxetan
2012
Completed Phase 2
~750
fludarabine phosphate
2000
Completed Phase 3
~2660
rituximab
2000
Completed Phase 3
~2760
melphalan
1994
Completed Phase 3
~3530
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
tacrolimus
2004
Completed Phase 4
~3750
sirolimus
2006
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,125 Total Patients Enrolled
1,513 Trials studying Leukemia
384,758 Patients Enrolled for Leukemia
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,619 Total Patients Enrolled
82 Trials studying Leukemia
4,943 Patients Enrolled for Leukemia
Auayporn P. Nademanee, MDStudy ChairCity of Hope Medical Center
3 Previous Clinical Trials
374 Total Patients Enrolled
1 Trials studying Leukemia
260 Patients Enrolled for Leukemia

Frequently Asked Questions

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

To what degree is allogeneic hematopoietic stem cell transplantation hazardous to individuals?

"According to our analysis, allogeneic hematopoietic stem cell transplantation is judged relatively safe due to the data collected during Phase 2 clinical trials. While safety has been documented there are no studies in regards to efficacy yet."

Answered by AI

Are there still opportunities to participate in this experiment?

"It appears that, according to records on clinicaltrials.gov, this research project is no longer seeking participants. Initially posted on October 3rd 2007 and last edited March 17th 2022, the trial has closed its enrollment process; however there are still 3984 other trials currently recruiting patients."

Answered by AI

Am I eligible to participate in this clinical research?

"This medical trial exclusively seeks lymphoma patients aged between 18 and 69; 54 volunteers are still required to complete the study."

Answered by AI

Is there an age restriction for participants of this clinical experiment?

"As laid out in the study's parameters, only those over 18 and under 69 qualify to join this clinical trial."

Answered by AI

Is the use of allogeneic hematopoietic stem cell transplantation a common practice in clinical research?

"Currently, there are 990 investigations into allogeneic hematopoietic stem cell transplantation with 152 of them in the late stages of clinical research. Most sites conducting these studies are located in Philadelphia, Pennsylvania; however, 15235 locations worldwide have initiated trials for this procedure."

Answered by AI

How many individuals have been invited to partake in this experiment?

"The research is not actively seeking participants at the present time. It was initially listed on October 3rd 2007 and last updated on March 17th 2022. If you are in search of other trials, there are currently 2994 clinical studies recruiting patients with lymphoma and 990 investigations looking for individuals to receive allogeneic hematopoietic stem cell transplantation."

Answered by AI

What afflictions can be remedied by allogeneic hematopoietic stem cell transplantation?

"Allogeneic hematopoietic stem cell transplantation is a commonly used therapy for organ transplants. Additionally, this treatment has been approved to help manage skin conditions like dermatitis and atopic as well as B-cell lymphomas and polyangium."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan
2007. "A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00577278.
~2 spots leftby Apr 2025
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