Safety of Romiplostim (Nplate®) Following UCBT
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | April 10, 2015 |
| End Date: | June 2019 |
Safety of Romiplostim (Nplate®) in Patients Who Have Failed to Achieve Platelet Engraftment Following Umbilical Cord Blood Transplant
This is a single institution, phase I dose escalation study of weekly romiplostim post
umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by
day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive
measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose
as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8,
and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim
determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to
identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20%
or less.
umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by
day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive
measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose
as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8,
and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim
determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to
identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20%
or less.
Inclusion Criteria:
- Any patient who has undergone a single or double umbilical cord blood transplant
(UCBT) except those with primary myelofibrosis.
- Those with acute leukemia must be in remission at the time of transplant
- Must have achieved neutrophil engraftment (defined as an ANC >500 for three
consecutive days) and be off daily G-CSF prior to starting romiplostim. Intermittent
G-CSF is allowed.
- Failure to achieve platelet engraftment (defined as platelet count ≥20x10^9/L on 3
consecutive measurements without transfusion for 7 days) by day +28 post UCBT
- Between day +28 and day +42 status post myeloablative or nonmyeloablative UCBT (single
or double cord blood transplant)
- Age ≥ 18 years
- Adequate organ function within 7 days of enrollment defined as:
- Creatinine: ≤ 2.0 mg/dL
- Hepatic: SGOT and SGPT < 5 x upper limit of institutional normal (ULN)
- Women of child bearing potential agree to use effective contraception during therapy
and for 4 months after completion of therapy
- Voluntary written consent
Exclusion Criteria:
- Known pregnancy - Pregnancy Category C: there are no adequate and well-controlled
studies of romiplostim in pregnancy
- Recurrence of AML or myelodysplastic syndrome on bone marrow evaluation done within 21
days of enrollment
- Presence of clinically significant bone marrow fibrosis on the bone marrow examination
immediately prior to UCBT
- Patients requiring more than one platelet transfusion per day
- History of an allergy to romiplostim
We found this trial at
1
site
Minneapolis, Minnesota 55455
Principal Investigator: Angela Smith, MD
Phone: 612-626-2778
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