NCT01670084

A Phase II Study of Combination Nilotinib and Hyper-CVAD in Patients Newly Diagnosed With Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia Blast-Phase Lymphoid Lineage

Withdrawn Phase 2 Last updated 29 October 2015

What this trial tests

Phase 2 trial testing nilotinib in B-cell Adult Acute Lymphoblastic Leukemia. Withdrawn.

Timeline

1 December 2012

Primary endpoint
1 September 2015

1 September 2017

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2012
Primary completion	1 September 2015
Estimated completion	1 September 2017
Sites	2 locations across United States

Drugs / interventions tested

• nilotinib
• rituximab
• cyclophosphamide (cyclophosphamide) — full drug profile →
• doxorubicin hydrochloride — full drug profile →
• vincristine sulfate (Vincristine Sulfate) — full drug profile →
• methotrexate
• cytarabine
• prednisone (prednisone) — full drug profile →
• mesna
• dexamethasone (dexamethasone) — full drug profile →
• leucovorin calcium

Conditions studied

• B-cell Adult Acute Lymphoblastic Leukemia — all drugs for B-cell Adult Acute Lymphoblastic Leukemia →
• Blastic Phase Chronic Myelogenous Leukemia — all drugs for Blastic Phase Chronic Myelogenous Leukemia →
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive — all drugs for Chronic Myelogenous Leukemia, BCR-ABL1 Positive →
• Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia — all drugs for Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 70, any sex, with B-cell Adult Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease-free survival rate, defined as a patient who is alive and relapse-free, in patients who achieve a CR during the first 2 courses out to 2 years
  Time frame: 2 years
  The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.

Sponsor's own description

In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation \[CD\]20 positive disease). Researchers don't know all the ways that this drug may affect people

Publications & conference data

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

1. Current concepts in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia.
   Bernt KM, Bernt KM, Hunger SP. · · 2014 · cited 100× · PMID 24724051 · DOI 10.3389/fonc.2014.00054
2. Trial watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Senovilla L, Eggermont A, Fridman WH, et al · · 2013 · cited 83× · PMID 23687621 · DOI 10.4161/onci.23510
3. Vitamin C Supplementation in the Treatment of Autoimmune and Onco-Hematological Diseases: From Prophylaxis to Adjuvant Therapy.
   Isola S, Gammeri L, Furci F, Gangemi S, et al · · 2024 · cited 15× · PMID 39000393 · DOI 10.3390/ijms25137284