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CompletedNCT00186342Updated Dec 17, 2012

Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies

An interventional study of ablative allogeneic hematopoietic cell transplantation in Acute Disease, Myelodysplastic Syndromes and Leukemia, Myeloid, Chronic, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 51 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-12-17.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
51 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).

Read the detailed description

To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.

02

Conditions studied

  • Acute Disease
  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Chronic
  • Myeloproliferative Disorders
  • Blood and Marrow Transplant (BMT)
  • Myelodysplastic Syndromes (MDS)
  • Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 120 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

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

04

Who can participate

Ages eligible
51 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.

  1. Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.
  1. Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.
  1. Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction
05

Study design

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

Study arms

  • Experimental
    CIK cell

    The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.

    Procedure: ablative allogeneic hematopoietic cell transplantation

Interventions

  • Procedureablative allogeneic hematopoietic cell transplantation
06

What researchers measure

Primary outcomes

  1. tolerability

  2. efficacy of therapy

Secondary outcomes

  1. compare efficacy of this treatment to historical controls

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00186342
Lead sponsor
Stanford University
Responsible party
Robert Negrin (Professor of Lymphatic Research and Medicine, Stanford University) — Principal investigator
First posted
Sep 16, 2005
Start date
Sep 1992
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Dec 17, 2012

Study contacts

Robert S Negrin
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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