Clinical trial · Interventional
Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer
Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unacceptable morbidity \& mortality
Summary
Brief summary (as posted)
RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
| umbilical cord blood transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Participants With 100 Day Transplant-related Mortality (TRM)
- timeFrame
- 100 days
- description
- 100 Day TRM is death within 100 days from transplant related complications
Secondary outcomes (5)
- measure
- Number of Patients That Engrafted Blood Counts by 30 Days After Transplant
- timeFrame
- Day 30
- description
- Number of patients whose Absolute Neutrophil Count (ANC) recovered to \>500 x10\^3/uL for at least 3 consecutive days after transplant
- measure
- Percentage of Donor and Host Chimerism of Each Cord Blood Unit
- timeFrame
- day 30, day 60, day 90
- description
- Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of hematologic malignancy for which a reduced-intensity allogeneic stem cell transplantation is deemed clinically appropriate, including any of the following:
* Chronic myelogenous leukemia, meeting one of the following criteria:
* In first chronic phase AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission by 3 months or major cytogenetic response (Ph+ cells \< 35%) by 12 months, or demonstrated clonal evolution or disease progression while on therapy
* In accelerated phase with \< 15% blasts
* In blast crisis that has entered into a second chronic phase following induction chemotherapy
* Acute myelogenous leukemia, meeting one of the following criteria:
* In second or subsequent completion remission\*
* Failed primary induction chemotherapy, but subsequently entered into a complete remission\* with ≤ 2 subsequent re-induction chemotherapy treatment(s)
* In first complete remission\* with poor-risk cytogenetics NOTE: \*Complete remission is defined as \< 5% blasts in bone marrow, no definitive evidence of disease by morphology, flow cytometry, or genetic studies, and no circulating blasts. Neutrophil and platelet count recovery will not be required.
* Acute lymphoblastic leukemia, meeting one of the following criteria:
* In second or subsequent complete remission
* In first complete remission AND t(9;22)
* Myelodysplastic syndromes, meeting the following criteria:
* High-risk disease, defined as International Prognostic Scoring System score of ≥ 1.5
* Less than 10% blasts at the time of study enrollment
* Chronic myelomonocytic leukemia
* Less than 10% blasts at the time of study enrollment
* Myeloid metaplasia with myelofibrosis with poor-risk features, meeting one of the following criteria:
* Age \< 55 years AND a Lille score of 1
* Lille score of 2
* Hemoglobin \< 10 g/dL AND abnormal karyotype
* Chronic lymphocytic leukemia/prolymphocytic leukemia, meeting all of the following criteria:
* Rai stage I-IV disease
* Failed ≥ 1 prior chemotherapy regimen, including fludarabine, or autologous stem cell transplantation
* Chemosensitive or stable, non-bulky disease prior to transplant
* Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered prior regimens)
* Low-grade B-cell non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma, follicular center \[grade 1 or 2\] lymphoma, or marginal zone lymphoma), meeting all of the following criteria:
* Failed ≥ 1 prior chemotherapy regimen or autologous stem cell transplantation
* Chemosensitive or stable, non-bulky disease prior to transplant
* Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered prior regimens)
* Intermediate-grade B-cell or T-cell NHL or mantle cell NHL, meeting all of the following criteria:
* Failed to achieve remission or recurred after either conventional chemotherapy or autologous stem cell transplantation
* Chemosensitive, non-bulky disease prior to transplant
* Hodgkin lymphoma, meeting all of the following criteria:
* Relapsed after prior autologous stem cell transplantation or after ≥ 2 combination chemotherapy regimens AND ineligible for autologous peripheral blood stem cell transplantation
* Chemosensitive, non-bulky disease prior to transplant
* Multiple myeloma, meeting one of the following criteria:
* Relapsed after autologous stem cell transplantation
* Relapsed after conventional therapies AND not a candidate for autologous stem cell transplantation
* No HLA-matched related or unrelated donor available
* Has two umbilical cord blood units available that are matched at ≥ 4/6 HLA A, B, and DRB1 with the patient and with each other (HLA C and DQ will not be used in the match strategy)
* Total combined nucleated cell dose from the 2 umbilical cord blood units must be \> 3.7 x 10\^7 nucleated cells/kg (pre-freeze dose) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
* Karnofsky performance status 80-100%
* Adapted, weighted Charlson Comorbidity Index \< 3
* Serum creatinine ≤ 2.0 mg/dL
* AST or ALT \< 3 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Not pregnant or nursing
* LVEF ≥ 40%
* DLCO \> 50%
* No hypoxia at rest with oxygen saturation \< 92% on room air (corrected with bronchodilator therapy)
* No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)
* No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate- to high-risk for developing severe hepatic disease
* No HIV infection
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
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