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Chemotherapy + Stem Cell Transplant for Lymphoma

Phase 1
Waitlist Available
Led By Amrita Y. Krishnan, 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 younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post stem cell reinfusion
Awards & highlights

Study Summary

This trial is studying the side effects of giving high-dose chemotherapy drugs and a stem cell transplant to treat patients with HIV-associated lymphoma.

Who is the study for?
This trial is for HIV-positive patients with lymphoma who have less than 10% bone marrow involvement, normal liver function tests, and a controlled HIV viral load on specific medication regimens. They must not be pregnant or nursing, have no severe infections or AIDS-related symptoms that could complicate the transplant process, and should have adequate organ function.Check my eligibility
What is being tested?
The study is testing high-dose chemotherapy drugs (carmustine, etoposide, cyclophosphamide) followed by returning the patient's own stem cells to treat cancer. The goal is to see how well this treatment works in patients with HIV-associated lymphoma and what side effects it may cause.See study design
What are the potential side effects?
Potential side effects include damage to blood-forming cells leading to low blood counts, increased risk of infection due to weakened immune system from chemotherapy and stem cell transplant procedures. There might also be organ-specific toxicities such as lung or heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post stem cell reinfusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post stem cell reinfusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility and treatment-associated toxicity of this regimen
Number of days to engraftment as defined by the standard operating procedures of the department of biostatistics at the City of Hope
Secondary outcome measures
Ability to mobilize adequate numbers of peripheral blood stem cells (2.5 x 10e6 CD34+cells)
Disease-free and overall survival
HIV viral load, CD4+/CD8+ counts, and immune recovery

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (high-dose chemotherapy, anti-HIV therapy)Experimental Treatment6 Interventions
Patients undergo leukapheresis to obtain PBSCs for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy. Patients receive carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients receive an autologous PBSC infusion on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carmustine
1994
Completed Phase 3
~2750
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
etoposide
1994
Completed Phase 3
~9300
cyclophosphamide
1994
Completed Phase 3
~8140
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,435 Total Patients Enrolled
97 Trials studying Lymphoma
6,445 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,375 Patients Enrolled for Lymphoma
Amrita Y. Krishnan, MDPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
139 Total Patients Enrolled
2 Trials studying Lymphoma
127 Patients Enrolled for Lymphoma

Media Library

Autologous Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT00641381 — Phase 1
Lymphoma Research Study Groups: Treatment (high-dose chemotherapy, anti-HIV therapy)
Lymphoma Clinical Trial 2023: Autologous Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT00641381 — Phase 1
Autologous Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT00641381 — Phase 1

Frequently Asked Questions

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

What are common applications of a pharmacological examination?

"Pharmacological interventions are frequently prescribed for lymphoma, but may also have positive results when treating acute lymphoblastic leukemia (ALL), glioblastomas and brain stem gliomas."

Answered by AI

Does this pharmacological investigation have the endorsement of the FDA?

"The pharmacological study is still in its earliest stages, so it was awarded a score of 1 due to the lack of data available on safety and efficacy."

Answered by AI

What other investigations have transpired related to pharmacological research?

"Of the 999 live clinical trials currently evaluating pharmacological interventions, 204 are at Phase 3. Though Philadelphia is a major hub for this research, there are 36320 sites globally dedicated to these studies."

Answered by AI

What is the enrollment size for this research project?

"Unfortunately, this research is not currently seeking volunteers. The study was initially posted on May 10th 2000 and last updated on February 17th 2022. If you are interested in alternative trials, there are 1,718 studies actively recruiting participants with lymphoma and 999 clinical investigations requiring volunteers for pharmacological evaluation."

Answered by AI

Does your research offer opportunities for me to get involved?

"To be considered for inclusion in this medical trial, applicants must lie within the 10 to 60 year old range and have lymphoma. Only 25 individuals can partake in the study upon its completion."

Answered by AI

Would someone who is 25 years old or older be able to become part of this experiment?

"The parameters for joining this clinical trial demand that participants be between 10 and 60 years old. There are 637 trials available for minors, and 2323 trials meant specifically for seniors."

Answered by AI

Are participants being recruited at this time for the trial?

"As per the data hosted on clinicaltrials.gov, this specific trial is not currently recruiting patients; it was initially posted in May 2000 and last updated in February 2022. Conversely, a total of 2717 other trials are looking for participants at present."

Answered by AI
~1 spots leftby Dec 2024