Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.
Leukemia · Myelodysplastic Syndrome · Non-Hodgkins Lymphoma · Chronic Myelogenous Leukemia · Hodgkins Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00739141 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival/PFS at 1 Year Post UCBT. |
84 | — |
| SECONDARY Number of Participants With Neutrophil Recovery Post Allograft for Haplo-dCBT Recipients |
17; 13; 13; 43 | — |
| SECONDARY Percentage of Participants With Sustained CB-derived Neutrophil Engraftment |
99 | — |
| SECONDARY Percentage of Participants With Sustained CB-derived Platelet Engraftment |
93 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- At least one cycle of induction or re-induction chemotherapy or lymphoma chemotherapy or azacitidine or decitabine or tyrosine kinase inhibitor.
- Patients aged 18-70 years at initial referral with no available and suitably matched related or unrelated donor.
- Acute myelogenous leukemia (AML):
- Complete first remission (CR1) at high risk for relapse such as:
- Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder;
- Therapy related AML;
- White cell count at presentation > 100,000;
- Presence of extramedullary leukemia at diagnosis;
- Any unfavorable sub type by FAB or WHO classification;
- High-risk cytogenetics (eg those associated with MDS, abnormalities of 5, 7, 8, Philadelphia chromosome, complex karyotype)or high risk molecular abnormalities;
- Requirement for 2 or more inductions to achieve CR1.
- Any patient with newly diagnosed AML with intermediate risk cytogenetics.
- Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.
- Complete second remission (CR2).
- Other acute leukemias that are ambiguous lineage or of other types eg blastic plasmacytoid dendritic cell neoplasm in CR1 or CR2
- Acute lymphoblastic leukemia (ALL):
- lymphoblastic leukemia (ALL):
- Complete first remission (CR1) at high risk for relapse such as:
- White cell count at presentation > 30,000 for B-cell lineage and >100,000 for Tcell lineage;
- Presence of a high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23)or other high-risk molecular abnormality;
- Failure to achieve complete remission after four weeks of induction therapy;
- Any patient with newly diagnosed ALL > or = to 50 years-old;
- Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician.
- Complete second remission (CR2).
- Myelodysplastic Syndrome (MDS):
- Intermediate-1 International Prognostic Scoring System (IPSS) score with poor risk cytogenetics as defined by IPSS.
- Intermediate- 2 or High International Prognostic Scoring System (IPSS) score.
- MDS/ myeloproliferative disorder overlap syndromes.
- Any score with life threatening cytopenia(s), including red cell or platelet transfusion dependence.
- Receipt of at least one cycle of cytotoxic chemotherapy, azacitidine or decitabine.
- MDS patients must have or = to 0.2 (growth factor supported if necessary) at transplant work-up.
- Myeloproliferative Disorder (MPD)
- Life-threatening cytopenia(s), and/or red blood cell or platelet transfusion dependence
- Patients with aplasia
- Patients with excess blasts less than or equal to 10% blasts in the bone marrow at work-up.
- Chronic myelogenous leukemia (CML) patients who have failed or are intolerant of tyrosine kinase inhibitors or patients with other myeloproliferative diseases who are high risk and the intent of therapy is cure.
- Any Non-Hodgkins lymphoma (including chronic lymphocytic leukemia)or Hodgkin's lymphoma at high-risk of relapse
- Eligible patients with DLC NHL will:
have relapsed disease following initial therapy but failed to mobilize or had bone marrow involvement and therefore are not suitable for an autologous transplant OR
- have failed an autologous transplant and be in CR after salvage chemotherapy.
- Eligible patients with transformed indolent NHL/CLL will:
have CR/PR of the large cell component of their disease after either salvage chemotherapy or an autologous transplant.
- Eligible patients with mantle cell NHL will:
be high-risk as such as p53 positivity and be in 1st CR/PR after initial therapy OR have relapsed disease following initial therapy and be in 2nd or 3rd CR/PR after salvage chemotherapy.
- Eligible patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) or CLL will have 2nd or subsequent progression (pre-allograft cytoreduction necessary bu
Data sourced from ClinicalTrials.gov (NCT00739141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.