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Phase 2 N=86 Treatment

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

Enrolled (actual)
86
Serious AEs
47.7%
Results posted
Dec 2022
Primary outcome: Primary: Progression Free Survival/PFS at 1 Year Post UCBT. — 84 percentage of participants

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

OutcomeResultp-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

The traditional way of doing a donor transplant is to give high doses of chemotherapy and radiation before giving the stem cells. However, high doses of chemotherapy and radiation can have serious side-effects. The doctors think that the transplant will be safer and more likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this study is to find out how good a combination of chemotherapy and radiation at reduced doses followed by a cord blood transplant are at treating cancer. The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood is collected from healthy newborn babies and frozen. One cord blood collection is called a "cord blood unit." On transplant day, the cord blood will be given through the catheter just like a blood transfusion. Transplants done this way have been successful. However, this type of transplant is fairly new. Therefore, it is important to study it so the doctors can better understand how it works. Most blood or bone marrow transplants using donor stem cells are done as part of a study. When patients are on a study we test new ways of treating them which we think may be better than the old ways. We collect information about the result of this treatment so we can understand how well the treatment works. This is so we can learn better ways to treat our patients.

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
View full record on ClinicalTrials.gov →

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.

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