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CD34+ Transplants for Myeloid Malignancies

ConditionsLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Acute
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuenther Koehne

About this trial

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AML in 1st remission-- for patients whose AML does not have "good risk" cytogenetic features (i.e., t(8;21), (q22; q22.1); RUNX1-RUNX1T1, inv16).

Secondary AML in 1st remission

AML in 1st relapse or 2nd remission

CML not responding adequately to TKI therapy, CML in accelerated phase or blast crisis, or CML in CR after accelerated phase or blast crisis

Disqualifiers

Individuals who are pregnant or breast-feeding

Uncontrolled bacterial, viral, or fungal infections; or known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection

Patients cured of Hepatitis C for ≥3 years prior to enrollment are permitted

Patients with detectable hepatitis B surface antigen (HBsAg) will be excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, will be eligible if HBV DNA is undetectable and if they are willing to be on hepatitis B antiviral prophylaxis and undergo monitoring for HBV reactivation (every 12 weeks while on immune suppression) per institutional protocols. Patients will be referred promptly to hepatology specialist with the first detectable viral load.

Trial design

Design model

Single group

Treatments tested in this trial

  • Busulfan

    Drug

    Busulfan: 0.8 mg/kg every 6 hours × 12 doses with dose modified according to pharmacokinetics

  • Melphalan

    Drug

    Melphalan: 70 mg/m²/day × 2

  • Fludarabine

    Drug

    Fludarabine: 25 mg/m²/day × 5

  • CD34+ Allogeneic Peripheral Blood Stem Cell Transplant

    Procedure/Surgery

    Allogeneic human leukocyte antigen (HLA)-compatible related or unrelated transplants of peripheral blood stem cells (PBSC) depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Busulfan/Melphalan/Fludarabine ConditioningExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

OS is defined as time from transplant to death due to any cause

Time frame
2 years

Secondary outcomes

1

Disease-Free Survival (DFS)

DFS is defined as the time from study treatment (transplant) to relapse, progression, or death from any cause, whichever occurs first.

Time frame
2 years
2

Transplant-Related Mortality (TRM)

TRM is defined as the percentage of participants whose cause of death was related to the transplant.

Time frame
2 years
3

Acute Graft versus Host Disease (GvHD)

Acute GvHD outcome is defined as the percentage of participants who develop acute GvHD

Time frame
2 years
4

Chronic GvHD

Chronic GvHD outcome is defined as the percentage of participants who develop chronic GvHD

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guenther Koehne

Lead sponsor

Baptist Health South Florida

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: