NCT02349178

Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

Terminated Phase 2 Results posted Last updated 9 March 2020

What this trial tests

Phase 2 trial testing Clofarabine in Leukemia, Acute Lymphoblastic in 6 participants. Terminated before completion.

Timeline

8 December 2014

Primary endpoint
16 March 2017

16 March 2017

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	8 December 2014
Primary completion	16 March 2017
Estimated completion	16 March 2017
Sites	4 locations across United States

Drugs / interventions tested

• Clofarabine (CLOFARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Etoposide (etoposide) — full drug profile →

Conditions studied

• Leukemia, Acute Lymphoblastic — all drugs for Leukemia, Acute Lymphoblastic →
• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Medical College of Wisconsin

Who can join

Under 39, any sex, with Leukemia, Acute Lymphoblastic or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Minimal Residual Disease Primary · Day 30 or adequate blood recovery

A bone marrow evaluation to determine study response and remission status will be performed on study Day 30 or upon adequate blood count recovery (ANC \> 0.50 and platelet \> 50,000), whichever occurs first. If the marrow is hypocellular and without evidence of normal tri-lineage hematopoiesis the marrow should be repeated at Day 42.

MRD Positive

Group	Value	95% CI
Bridging Arm	3

MRD Negative

Group	Value	95% CI
Bridging Arm	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 60 from start of study drug. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bridging Arm

Serious: 2/6 (33%)

Deaths: 0/6

Serious adverse events (2 terms)

Reaction	System	Bridging Arm
acute kidney injury	Renal and urinary disorders	—
Sepsis	Infections and infestations	—

Most-reported serious reactions: acute kidney injury, Sepsis.

Data from ClinicalTrials.gov NCT02349178 adverse events section.

Sponsor's own description

This is a Phase 2 study designed for the purpose of estimating various parameters surrounding the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual disease (MRD) in acute leukemia patients otherwise in remission and without causing significant delay of HCT due to treatment related toxicity.

A single course of "bridge" chemotherapy is given prior to the transplant procedure as an approach to improved disease-free survival in a patient group who historically has had inferior outcomes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. MRD Tailored Therapy in AML: What We Have Learned So Far.
   Ngai LL, Kelder A, Janssen JJWM, Ossenkoppele GJ, et al · · 2020 · cited 37× · PMID 33575214 · DOI 10.3389/fonc.2020.603636
2. Minimal Residual Disease in Acute Myeloid Leukemia: Still a Work in Progress?
   Mosna F, Capelli D, Gottardi M. · · 2017 · cited 25× · PMID 28587190 · DOI 10.3390/jcm6060057