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Chemotherapy

Cord Blood Transplant for Blood Cancers in HIV Patients

Phase 2
Recruiting
Led By Filippo Milano
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute myeloid leukemia:
Chronic myelogenous leukemia excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying the side effects of a cord blood transplant using OTS to treat patients with HIV positive hematologic cancers.

Who is the study for?
This trial is for HIV-positive adults and children with various high-risk blood cancers who are in remission but have a history of difficult treatment responses. Participants must be on effective anti-HIV drugs, have controlled viral loads, and meet specific health criteria like proper kidney function and heart performance. Pregnant or breastfeeding individuals, those with recent invasive infections or CNS leukemia not responding to therapy, or anyone who's had a myeloablative transplant within the last 6 months cannot join.Check my eligibility
What is being tested?
The study tests dilanubicel in cord blood transplantation alongside chemotherapy (fludarabine, cyclophosphamide, thiotepa) and total-body irradiation for treating HIV-positive patients with hematologic cancers. The goal is to see how well dilanubicel helps recover immune cells post-transplant to reduce infection risk while targeting any remaining cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions from the stem cell transplant such as graft-versus-host disease, infections due to weakened immunity from chemotherapy and radiation treatments, organ damage from medications used during the process, fatigue, nausea, hair loss and increased bleeding risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have acute myeloid leukemia.
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I have chronic myelogenous leukemia and cannot take or did not respond to imatinib.
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My kidney function is good, with creatinine clearance over 60 mL/min and serum creatinine 2 mg/dL or less.
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My viral load is under 5000 copies/ml while on treatment.
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My blood disorder is at a high risk level, but less than 10% of my bone marrow cells are immature.
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My lung function is more than half of what is considered normal.
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My leukemia is considered high risk due to specific genetic features or because it took more than one treatment cycle to respond.
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My blood cancer is in complete remission with specific bone marrow recovery indicators.
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I am mostly independent and can care for myself.
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My child's kidneys filter waste well (over 60 mL/min).
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I am between 6 months and 65 years old.
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My child can do most activities but needs help sometimes.
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My condition is acute lymphoblastic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Primary graft failure rejection
Secondary outcome measures
Change in HIV-1 induced inflammatory immune responses
Chronic GVHD
HIV rebound following antiretroviral therapy (ART) cessation
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Regimen B (anticancer drugs, TBI, dilanubicel)Experimental Treatment6 Interventions
Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.
Group II: Regimen A (fludarabine, cyclophosphamide, TBI, dilanubcel)Experimental Treatment5 Interventions
Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thiotepa
2008
Completed Phase 3
~2150
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Total-Body Irradiation
1997
Completed Phase 3
~1180
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,660 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,235 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,258 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04083170 — Phase 2
HIV/AIDS Research Study Groups: Regimen B (anticancer drugs, TBI, dilanubicel), Regimen A (fludarabine, cyclophosphamide, TBI, dilanubcel)
HIV/AIDS Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04083170 — Phase 2
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083170 — Phase 2

Frequently Asked Questions

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

Is it possible to join this research program?

"Eligibility requirements for this study necessitate that participants must be suffering from refractory anemia and within the age range of 6 Months to 65. A total of 10 individuals will be selected to take part in the trial."

Answered by AI

Is the age cutoff for this experiment set at sixty years old or lower?

"This trial is only open to participants aged between 6 Months and 65 years old. For the younger demographic, 1236 clinical trials are available while 3235 can be found for senior citizens."

Answered by AI

How many individuals are currently participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov reflects that this trial, which began inviting applicants on October 6th 2022, is still recruiting participants to join the study. The data suggests a need for 10 individuals from 5 distinct locations."

Answered by AI

For what medical conditions is Total-Body Irradiation a common treatment?

"Total-Body Irradiation is a viable treatment option for a range of diseases, including multiple sclerosis, leukemia, myelocytic anemia, acute lymphoblastic leukaemia and retinoblastoma."

Answered by AI

Could you provide information about any further experiments involving Total-Body Irradiation?

"At present, 897 Total-Body Irradiation studies are being conducted with 161 of those in Phase 3. Primarily based in Philadelphia, Pennsylvania, these trials can be found at 28,617 different locations worldwide."

Answered by AI

In what geographical areas is this trial currently active?

"This trial is enrolling patients at sites such as Case Western Reserve University in Seattle, Washington; Fred Hutch/University of Washington Cancer Consortium in San Francisco, California; and the University of California San Francisco located within the District of Columbia. In addition to these locations, there are 5 other potential clinical trial centres that qualify for enrolment."

Answered by AI

Has Total-Body Irradiation been granted sanction by the FDA?

"According to our Power team, Total-Body Irradiation scored a 2 on the safety scale. This is because Phase 2 trials have provided data that indicates some level of safety but none confirming efficacy."

Answered by AI

Is enrollment into this experiment still open?

"According to clinicaltrials.gov, this trial is still looking for volunteers and was originally posted on October 6th 2022 before being updated November 1st of the same year."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers
2022. "Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04083170.
~3 spots leftby Dec 2024
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