New Two-Step transplant shows promise for tough blood cancers
NCT ID NCT01315132
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tested a two-step stem cell transplant approach for 47 patients with high-risk blood cancers like leukemia and lymphoma. The method uses the drug cyclophosphamide to lower the chance of graft-versus-host disease (GVHD), a common complication. The goal was to see if more than 60% of patients would survive at least one year after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyclophosphamide
- What this could lead to
- If successful, this approach could improve survival and reduce severe graft-versus-host disease in patients with high-risk blood cancers receiving a stem cell transplant from a matched sibling.
- What could go wrong
- This is a small, completed phase 2 trial with only 47 participants, so results may not apply to all patients. The treatment still carries risks of infection, organ damage, and GVHD.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
47 people
The number who actually took part.
- Started
-
Apr 2008
- Finished
-
Aug 2019
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following: 1. Age \> 50 years 2. ECOG Performance status of \<2 3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL 4. CML 2nd chronic phase, accelerated phase, or blastic phase 5. MDS with IPS of Intermediate 2 or greater 6. Any myeloproliferative disorder 7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure 8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT 9. Other conditions not listed will be assessed as high-risk by the PI 2. Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci. 3. Patients must adequate organ function: 1. LVEF of \>45% 2. DLCO (adjusted for hemoglobin) \>45% of predicted 3. Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal 4. Creatinine clearance of \> 60 ml/min 4. Patients must be willing to use contraception if they have childbearing potential 5. Able to give informed consent Exclusion Criteria: 1. ECOG performance status of 3 or 4. 2. HIV positive 3. Active involvement of the central nervous system with malignancy 4. Psychiatric disorder that would preclude patients from signing an informed consent 5. Pregnancy 6. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder.
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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
-
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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