Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
Condition: Leukemia; Lymphoma; Multiple Myeloma; Plasma Cell Neoplasm; Myelodysplastic Syndromes
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Hematologic Neoplasms; Plasmacytoma; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to
      accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an
      umbilical cord blood transplant for hematologic cancer. In this study, the safety and
      tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will
      be determined by monitoring for adverse reactions, neutrophil and platelet recovery,
      hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.
    


Intervention name(s): human myeloid progenitor cells
Intervention type(s): Biological
Intervention description(s): Single intravenous injection/infusion
Other intervention name(s): CLT-008; hMPC
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adult acute myeloid leukemia 11q23 (MLL) abnormalities; adult acute myeloid leukemia inv(16)(p13;q22); adult acute myeloid leukemia t(15;17)(q22;q12); adult acute myeloid leukemia t(16;16)(p13;q22); adult acute myeloid leukemia t(8;21)(q22;q22); accelerated phase chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; chronic phase chronic myelogenous leukemia; de novo myelodysplastic syndromes; extranodal marginal zone B-cell lymphoma; mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; stage I adult Burkitt lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; Waldenstrom macroglobulinemia; noncontiguous stage II adult immunoblastic; contiguous stage II adult immunoblastic; large cell lymphoma; stage I adult immunoblastic large cell lymphoma; previously treated myelodysplastic syndromes; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; refractory multiple myeloma; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; secondary myelodysplastic syndromes; splenic marginal zone lymphoma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; stage III adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; refractory anemia; prolymphocytic leukemia; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; refractory chronic lymphocytic leukemia; stage IV adult Burkitt lymphoma; stage I childhood small noncleaved cell lymphoma; stage II childhood small noncleaved cell lymphoma; stage III childhood small noncleaved cell lymphoma; stage IV childhood small noncleaved cell lymphoma; recurrent childhood small noncleaved cell lymphoma; stage I childhood large cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; stage I mantle cell lymphoma; stage I adult lymphoblastic lymphoma; stage I adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; recurrent childhood large cell lymphoma; stage I childhood lymphoblastic lymphoma; stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage IV childhood lymphoblastic lymphoma; recurrent childhood lymphoblastic lymphoma; childhood myelodysplastic syndromes; Burkitt lymphoma