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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 up to 5 years
Awards & highlights
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
596 Previous Clinical Trials
1,923,512 Total Patients Enrolled
101 Trials studying Lymphoma
6,535 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,975 Total Patients Enrolled
1,399 Trials studying Lymphoma
382,838 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an ongoing bacterial or fungal infection.I haven't had any AIDS-related infections in the past year, except for treatable conditions like Mycobacterium Avium, oral thrush, or herpes.I am mostly able to care for myself.You have mental or emotional conditions that make it difficult for you to follow the study requirements.I have had severe bladder inflammation from past chemotherapy.I have had cancer before, but it was either skin cancer treated successfully or cervical changes, depending on my doctor's advice.I am on a preventive treatment for a specific type of pneumonia due to low immune cells.I cannot take AZT for at least 2 months after my transplant.My heart pumps well and I don't have heart failure or irregular heartbeat.I have severe, uncontrollable diarrhea causing serious health issues.I currently have an active CMV infection affecting my eyes or other organs.I do not have AIDS-related conditions that increase risk for transplant complications.I had a relapse of a specific type of pneumonia in the last year.My spinal fluid test was negative for cancer cells within the last 30 days after treatment.I was HIV positive when or before my lymphoma was diagnosed.My bone marrow involvement is less than 10% before stem cell collection.I am a woman who can have children and my pregnancy test is negative.I am on HIV medication and meet the specific viral load requirements.I have Hepatitis B or C but no signs of severe liver damage, pending further tests.My lymphoma is confirmed to be of a specific aggressive type, not including L&H lymphocyte predominant.My kidney function tests are within normal limits.My cancer can be measured by scans or physically, and is not in complete remission.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (high-dose chemotherapy, anti-HIV therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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