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Haplo-identical SCT for High Risk (HR) Hematologic Malignancies w/Post-Transplant In-Vivo T-cell Depletion

NCT02053545 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-08-30

No results posted yet for this study

Summary

Although a majority of children with leukemia and most hematological malignancies (Hodgkin's and Non-Hodgkin's lymphomas) can be cured with conventional chemotherapy, a subset of patients with resistant/recurrent high-risk disease are not cured with conventional treatment regimens. Investigators hypothesize that HSCT from a partially matched donor can be safe and effective for patients with very high risk hematologic malignancies when combined with post-transplant cyclophosphamide for prevention of graft-vs-host disease (GVHD).

Conditions

Interventions

DRUG

Conditioning Regimen & GVHD Prophylaxis

Stratum 1 (Refractory disease, relapse after previous transplant): Radiation Therapy (if patient had prior Central Nervous System (CNS) disease), Clofarabine, Melphalan,Thiotepa, Stem Cell Transplant, Cyclophosphamide, Mesna, Tacrolimus and MMF Stratum 2 (Myeloid in remission): Radiation Therapy (if patient had prior CNS disease), Busulfan, Fludarabine, Thiotepa, Stem Cell Transplant, Cyclophosphamide, Mesna, Tacrolimus, MMF Stratum 3 (Lymphoid in remission): Radiation Therapy (if patient had prior CNS disease), TBI, Fludarabine, Thiotepa, Stem Cell Transplant, Cyclophosphamide, Mesna, Tacrolimus, MMF

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Reggie Duerst, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-05-11
Completion
2017-05-11

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053545 on ClinicalTrials.gov