New Two-Step transplant shows promise for blood cancer patients
NCT ID NCT01384513
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a two-step stem cell transplant for people with blood cancers like leukemia and lymphoma. First, patients received low-dose chemotherapy and radiation to prepare their bodies. Then, they got donor stem cells followed by drugs to prevent the donor cells from attacking their own body. The goal was to see if this approach could improve survival and control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Started
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Aug 2011
- Finished
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Nov 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Any patient with hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients treated on this protocol will be without morphological evidence of disease (complete remission or "CR"), or if the patient has evidence of disease, the patient must have had at least a good partial response (PR) to the most recent therapy and the disease must be chemoresponsive. 2. Patients treated on this study will have: * Acute leukemia in 1st or 2nd CR * MDS (myelodysplastic syndrome), specific subtypes of RA (refractory anemia) or RARS (refractory anemia with ringed sideroblasts) subtypes. * Hodgkin or Indolent Non-Hodgkin's lymphoma with chemosensitive disease * Myeloma without morphological evidence of disease, or a deep PR to the most recent therapy * Myeloproliferative disorders with at least a PR to current therapy * Aplastic Anemia * A hematological or oncological disease (not listed) that meets the criteria reviewed above (in CR or with a good PR). 3. Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Summary section). 4. Patients must adequate organ function: * LVEF (Left ventricular end diastolic function) of \>50% * DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) ≥50% of predicted corrected for hemoglobin * Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal * Creatinine Clearance of ≥ 60 mL/min 5. Performance status ≥ 80% (TJU Karnofsky) for patients ≥ 60 years old or ≥70% for patients \< 60 years old. 6. HCT-CI Score ≤ 4 points for patients ≥ 60 years old or ≤ 5 points for patients \< 60 years old. • Patients must have adequate Karnofsky performance status (KPS) and hematopoietic cell transplantation comorbidity index (HCT-CI) scores: * Patients \< age 60 years must have a KPS of \>= 80% and an HCT-CI score of 5 or less * Patients aged 60 to 65 years must have a KPS of \>= 80% and an HCT-CI score of 4 or less * Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less * Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less * Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (Co-I) not on the primary care team of the patient; this is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points; an example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities 7. Patients must be willing to use contraception if they have childbearing potential 8. Able to give informed consent Exclusion Criteria: * Human immunodeficiency virus (HIV) positive * Active involvement of the central nervous system with malignancy * Inability to obtain informed consent * Pregnancy * Patients with life expectancy of =\< 6 months for reasons other than their underlying hematologic/oncologic disorder * Patients who have received alemtuzumab or anti-thymocyte globulin (ATG) within 8 weeks of the transplant admission; (documented by the absence of these agents in the medical record) * Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Half-Matched stem cells tested as a cure for severe aplastic anemia
- Tweaking donor cells may shield older transplant patients from a dangerous complication
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- New drug combination targets Hard-to-Treat blood cancers
- Can a calming drug make cord blood transplants safer?