35 Participants Needed

Cord Blood Transplantation for Blood Cancers

WF
Overseen ByWarren Fingrut, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What data supports the effectiveness of the treatment Cyclophosphamide, Fludarabine, and Thiotepa for blood cancers?

Research shows that using Cyclophosphamide, Fludarabine, and Thiotepa in cord blood transplants can lead to high rates of successful engraftment (when transplanted cells start to grow and make healthy blood cells) and improved survival rates in patients with blood cancers. These drugs, when used together, have been associated with lower relapse rates and better overall survival compared to some other treatment regimens.12345

Is cord blood transplantation safe for treating blood cancers?

Cord blood transplantation has been studied for safety, showing that while it can lead to complications like graft-versus-host disease (a condition where the donor cells attack the recipient's body) and organ toxicity, many patients achieve successful engraftment (when the transplanted cells start to grow and make healthy blood cells). Treatment-related deaths can occur, but survival rates are promising, indicating it is generally safe with careful monitoring.23567

How is the cord blood transplantation treatment with Cyclophosphamide, Fludarabine, and Thiotepa different from other treatments for blood cancers?

This treatment is unique because it uses umbilical cord blood from unrelated donors, which can be an option for patients who do not have a matched donor. The combination of Cyclophosphamide, Fludarabine, and Thiotepa is part of a conditioning regimen that prepares the body for the transplant, aiming to improve survival rates in patients with advanced blood cancers.2891011

What is the purpose of this trial?

The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.

Research Team

WF

Warren Fingrut, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients aged 0-60 with high-risk blood cancers who have relapsed after their first stem cell transplant. They must be in good physical condition, with a Karnofsky score of at least 70%, proper heart and kidney function, and specific diagnoses like AML or ALL in remission. Pregnant individuals, those not using contraception, or with uncontrolled infections/GVHD can't participate.

Inclusion Criteria

I am mostly able to care for myself but may need help.
Left ventricular ejection fraction (MOD-bp) > 50%
My kidneys work well (creatinine clearance over 50 ml/min).
See 10 more

Exclusion Criteria

Pregnant or breastfeeding
I have an ongoing and uncontrolled infection.
Women of child-bearing potential and men not using adequate contraception
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Therapy

Participants receive intermediate-intensity conditioning therapy prior to cord blood transplant

2-3 weeks

Cord Blood Transplantation

Participants undergo cord blood transplantation to control high-risk hematological malignancies

1 week

Follow-up

Participants are monitored for safety, effectiveness, and adverse events after transplantation

1 year

Treatment Details

Interventions

  • Cyclophosphamide
  • Fludarabine
  • Thiotepa
Trial Overview The study tests if intermediate-intensity conditioning therapy followed by cord blood transplantation can control high-risk hematological malignancies in patients needing a second allogeneic stem cell transplant. Drugs used include Cyclophosphamide, Thiotepa, Mycophenolate mofetil, Fludarabine, and Tacrolimus.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Optimized CBTExperimental Treatment5 Interventions
Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

In a multicenter phase II study involving 53 patients, double umbilical cord blood transplantation showed a high engraftment rate of 92% with a median neutrophil recovery time of 36 days, indicating its efficacy in treating high-risk hematological malignancies.
The study found that early CD4(+) T-cell chimerism can predict the survival of the transplanted units, suggesting that CD4(+) lymphocytes may play a role in the success of the transplantation process.
Rapid induction of single donor chimerism after double umbilical cord blood transplantation preceded by reduced intensity conditioning: results of the HOVON 106 phase II study.Somers, JA., Braakman, E., van der Holt, B., et al.[2021]
A conditioning regimen using melphalan, thiotepa, fludarabine, and rabbit antithymocyte globulin (FMT) was evaluated in 47 patients with advanced hematologic malignancies, showing that 91% of patients successfully engrafted neutrophils after a median of 22 days, indicating effective hematopoietic recovery.
Despite a significant incidence of grade 3 gastrointestinal toxicity (32%) and a cumulative incidence of acute and chronic graft-versus-host disease (53% and 34%, respectively), the two-year disease-free survival rate was 31% and overall survival rate was 44%, suggesting that FMT is a feasible and potentially effective conditioning regimen for unrelated cord blood transplants.
Fludarabine, melphalan, thiotepa and anti-thymocyte globulin conditioning for unrelated cord blood transplant.Ciurea, SO., Saliba, RM., Hamerschlak, N., et al.[2021]
In a study of 81 patients with hematological diseases undergoing unrelated umbilical cord blood transplantation (UCBT), 96.3% achieved complete engraftment, indicating high efficacy of the treatment protocol.
The combination of high-dose cyclophosphamide and fludarabine conditioning before UCBT was effective in enhancing stem cell engraftment and improving overall survival rates, which were reported at 80.2% by the end of follow-up.
A New Conditioning Regimen Can Significantly Promote Post-Transplant Immune Reconstitution and Improve the Outcome of Umbilical Cord Blood Transplantation for Patients.Yu, ZP., Ding, JH., Sun, AN., et al.[2020]

References

Rapid induction of single donor chimerism after double umbilical cord blood transplantation preceded by reduced intensity conditioning: results of the HOVON 106 phase II study. [2021]
Fludarabine, melphalan, thiotepa and anti-thymocyte globulin conditioning for unrelated cord blood transplant. [2021]
A New Conditioning Regimen Can Significantly Promote Post-Transplant Immune Reconstitution and Improve the Outcome of Umbilical Cord Blood Transplantation for Patients. [2020]
Thiotepa-Based Intensified Reduced-Intensity Conditioning Adult Double-Unit Cord Blood Hematopoietic Stem Cell Transplantation Results in Decreased Relapse Rate and Improved Survival Compared with Transplantation Following Standard Reduced-Intensity Conditioning: A Retrospective Cohort Comparison. [2019]
Adult Umbilical Cord Blood Transplantation Using Myeloablative Thiotepa, Total Body Irradiation, and Fludarabine Conditioning. [2018]
Non-radiotherapy conditioning with stem cell transplantation from alternative donors in children with refractory severe aplastic anemia. [2013]
Higher Fludarabine and Cyclophosphamide Exposures Lead to Worse Outcomes in Reduced-Intensity Conditioning Hematopoietic Cell Transplantation for Adult Hematologic Malignancy. [2021]
Umbilical cord blood transplantation from unrelated donors in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. [2022]
Sequential Transplantation of Haploidentical Stem Cell and Unrelated Cord Blood With Using ATG/PTCY Increases Survival of Relapsed/Refractory Hematologic Malignancies. [2021]
Reduced-intensity conditioning followed by unrelated umbilical cord blood transplantation for advanced hematologic malignancies: rapid engraftment in bone marrow. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Single-unit umbilical cord blood transplantation from unrelated donors in adult patients with chronic myelogenous leukemia. [2010]
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