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New Two-Step transplant shows promise for blood cancer patients

NCT ID NCT01384513

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

40 people

The number who actually took part.

Started

Aug 2011

Finished

Nov 2022

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.

Show 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.

acquired polycythemia vera acute leukemia acute myeloid leukemia acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute promyelocytic leukemia adult acute lymphoblastic leukemia aplastic anemia B-cell chronic lymphocytic leukemia Burkitt lymphoma childhood acute lymphoblastic leukemia childhood acute myeloid leukemia childhood myelodysplastic syndrome chronic eosinophilic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma chronic myelomonocytic leukemia chronic neutrophilic leukemia Congenital Abnormalities essential thrombocythemia extranodal nasal NK/T cell lymphoma follicular lymphoma grade III lymphomatoid granulomatosis hairy cell leukemia Hodgkins lymphoma indolent B-cell non-Hodgkin lymphoma juvenile myelomonocytic leukemia Leukemia, Large Granular Lymphocytic Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell MALT lymphoma marginal zone lymphoma mastocytosis mycosis fungoides myelodysplastic syndrome myelodysplastic syndrome with ring sideroblasts myelodysplastic syndrome with single lineage dysplasia myelodysplastic/myeloproliferative neoplasm Myeloproliferative Disorders myeloproliferative neoplasm nodal marginal zone B-cell lymphoma non-Hodgkin lymphoma plasma cell myeloma Precursor Cell Lymphoblastic Leukemia-Lymphoma primary cutaneous T-cell non-Hodgkin lymphoma primary myelofibrosis Recurrence refractory hairy cell leukemia refractory plasma cell neoplasm Sezary syndrome splenic marginal zone lymphoma T-cell large granular lymphocyte leukemia therapy-related myeloid neoplasm Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult acute lymphoblastic leukemia in remission Adult acute myeloid leukemia in remission Adult acute myeloid leukemia with 11q23 (MLL) abnormalities Adult acute myeloid leukemia with del(5q) Adult acute myeloid leukemia with inv(16)(P13;Q22) Adult acute myeloid leukemia with T(15;17)(Q22;Q12) Adult acute myeloid leukemia with T(16;16)(P13;Q22) Adult acute myeloid leukemia with T(8;21)(Q22;Q22) Adult nasal type extranodal NK/T-cell lymphoma Aplastic anemia Childhood acute lymphoblastic leukemia in remission Childhood acute myeloid leukemia in remission Childhood myelodysplastic syndromes Chronic eosinophilic leukemia Chronic myelomonocytic leukemia Chronic neutrophilic leukemia Essential thrombocythemia Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue Juvenile myelomonocytic leukemia Mastocytosis Myelodysplastic/myeloproliferative neoplasm, unclassifiable Nodal marginal zone B-cell lymphoma Polycythemia vera Previously treated myelodysplastic syndromes Primary myelofibrosis Recurrent adult acute lymphoblastic leukemia Recurrent adult acute myeloid leukemia Recurrent adult diffuse small cleaved cell lymphoma Recurrent adult grade III lymphomatoid granulomatosis Recurrent adult Hodgkin lymphoma Recurrent childhood acute lymphoblastic leukemia Recurrent childhood acute myeloid leukemia Recurrent cutaneous T-cell non-Hodgkin lymphoma Recurrent grade 1 follicular lymphoma Recurrent grade 2 follicular lymphoma Recurrent marginal zone lymphoma Recurrent mycosis fungoides/sezary syndrome Recurrent small lymphocytic lymphoma Recurrent/refractory childhood Hodgkin lymphoma Refractory anemia Refractory anemia with ringed sideroblasts Refractory hairy cell leukemia Refractory multiple myeloma Secondary myelodysplastic syndromes Splenic marginal zone lymphoma T-cell large granular lymphocyte leukemia Waldenström macroglobulinemia

Contacts and locations

Locations

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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