Pediatric Acute Lymphoblastic Leukemia, Relapsed Clinical Trial
— BMTAMD3100Official title:
A Pilot Study of AMD3100 as a Sensitizing Agent in Myeloablative Allogeneic Blood and Marrow Transplantation for Chemotherapy Resistant Pediatric Acute Leukemia
| Verified date | April 2014 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is for patients 2-21 years old who have acute leukemia that has not responded
well to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study
of AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard
pre-transplant conditioning regimen (total body irradiation, etoposide and
cyclophosphamide). The conditioning regimen is the treatment that is given just before the
transplant. This treatment kills leukemia cells as well as healthy bone marrow and immune
cells. Researchers want to learn more about how AMD3100 affects acute leukemia cells. Blood
and bone marrow samples from study participants will be collected to find out if AMD3100 is
making patients' cells more sensitive to the conditioning regimen and to find out how it
does this.
The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that
three doses do not significantly increase the side effects of transplant conditioning, the
investigators will give a second group of six patients five daily doses.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 22 Years |
| Eligibility |
Inclusion Criteria: - Must have chemotherapy-resistant acute leukemia (primary refractory or relapsed and refractory AML, ALL, undifferentiated, bi-lineage or mixed lineage leukemia) - Participant must have a well HLA matched related, mismatched related or unrelated marrow donor with whom the patient is allele matched at at least 7 of 8 HLA loci or a single unrelated cord blood unit matched at at least 4 of 6 HLA loci with minimal dose of 4x10(7)NC/Kg Exclusion Criteria: - Prior allogeneic or autologous hematopoietic stem cell transplantation - Prior exposure to AMD3100 - Active central nervous system leukemia - Uncontrolled viral, bacterial, fungal, protozoal infection - HIV infection - Does not meet standard organ function for transplant |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AMD3100 safety | Incidence of grade 3 and 4 regimen-related toxicity assessed per Bearman scale at day 42. Patients in dose level 1 get 3 days of AMD3100. If 2 cases of grade 4 toxicity or 3 cases of grade 3-4 toxicity occur, dose level 1 and study will be closed. Otherwise, after 6 patients have been assessed at day 42, the dose will be escalated to 5 days of AMD3100 (dose level 2). If 2 cases of grade 4 toxicity or 3 cases of grade 3-4 toxicity occur, the study will be closed. Otherwise, after 6 patients have been enrolled at this level the study will be closed to enrollment. | day 42 after bone marrow transplant | Yes |
| Secondary | AMD3100 correlative biology analyses | Bone marrow and peripheral blood samples collected during study are examined in the laboratory to detect if there is any difference in leukemia cells after treatment with AMD3100. | 2 years | No |