CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Fludarabine +4 moredrug
Likely dose
Fludarabine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02556931
NCT02556931Phase 2Completed
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Phase II Study of Shortened-duration Tacrolimus Following Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Malignancies That Are Challenging to Engraft

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Sep 22, 2015·Updated Nov 3, 2022

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide, and 3 other interventions for Myelodysplastic Syndrome and 13 related conditions. Completed, enrolled 117 participants across 1 site.

Detailed Summary

To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Chronic Myeloid Leukemia, Chronic Myeloproliferative Disorders, Multiple Myeloma, Plasma Cell Neoplasm, Plasma Cell Dyscrasia, Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia, Plasma Cell Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 22, 2015
Enrollment StartDec 1, 2015
Primary CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.8 years ago

Interventions

Fludarabinedrug

Days -6 through -2: 30 mg/m\^2 IV daily

Cyclophosphamidedrug

Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily

Total body irradiationradiation

Day -1: 200 cGy in a single fraction

Tacrolimusdrug

Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status.

Mycophenolate mofetildrug

Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)