Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 60
SponsorM.D. Anderson Cancer Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.

Patient must have relapsed >100 days since first transplant.

Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).

Calculated creatinine clearance > 50 ml/min.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Drugs Cyclophosphamide

    Drug

    Given as standard of care treatment through IV infusion

  • Fludarabine

    Drug

    Given as standard of care treatment through IV infusion

  • Thiotepa

    Drug

    Given as standard of care treatment through IV infusion

  • Tacrolimus

    Drug

    Given as standard of care treatment through IV infusion

  • Mycophenolate mofetil

    Drug

    Given as standard of care treatment through IV infusion

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Optimized CBTExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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