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TerminatedNCT00038779Updated Oct 30, 2018

Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

An interventional study of Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation in Leukemia, Non Hodgkin's Lymphoma and Aplastic Anemia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged Up to 49 Years. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of Accrual

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Aug 1996, registered Jun 2002).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
Up to 49 Years
Sex
All
01

Study summary

The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.

02

Conditions studied

  • Leukemia
  • Non Hodgkin's Lymphoma
  • Aplastic Anemia

Keywords

  • Lymphoma
  • CML
  • CLL
  • AML
  • ALL
  • MDS
  • AA
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's enrollment of 7 is below the median of 38 across 4,268 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.

Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.

Browse M.D. Anderson Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
  • Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
  • Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
  • Patients must be \<age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.
  • Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.
  • Patients with serious intercurrent medical illness are not eligible.
  • Patients and their donors must provide written informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Megadose T cell depleted

    Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Interventions

  • ProcedureMegadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation
06

Study locations

1 site
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
07

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 1996 to primary completion in Sep 2004, 97 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2002
First posted
Jun 7, 2002
StartActual
Aug 14, 1996
Primary completionActual
Sep 20, 2004
CompletionActual
Sep 20, 2004
Last update
Oct 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00038779
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jun 7, 2002
Start date
Aug 14, 1996
Primary completion
Sep 20, 2004
Completion
Sep 20, 2004
Last update
Oct 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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