Showing 1 - 10 of 45 records.

20130320-BITE: An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Rialto Study)

  • Conditions: Cancer - Leukemia and Lymphoma
  • Gender: Female, Male

Primary Objective: To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other t ...More

20140106-CFZ008: Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

  • Conditions: Cancer - Leukemia and Lymphoma, Leukemia ALL Relapse

PURPOSE: The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). ARM INFORMATION: EXPERIMENT ...More

AALL0622: Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/ Therapy for New Diagnosis Very High Risk Disease

  • Conditions: Adult Studies, Cancer - Leukemia and Lymphoma
  • Gender: Female, Male

This study builds on the experience of AALL0031 which safely incorporated imatinib into an intensive chemotherapy backbone for pediatric patients with Ph+ ALL. The proposed treatment plan intensifies AALL0031 TKI therapy and includes substitution of dasatinib for imatinib. AALL0622 patients will rec ...More

AALL0631: A Phase III Study of Risk Directed Therapy for Infants with ALL: Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431)/ Therapy for New Diagnosis Very High Risk Disease

  • Conditions: Cancer - Leukemia and Lymphoma
  • Gender: Female, Male

Primary To compare the 3-year event-free survival of infants with mixed lineage leukemia rearranged (MLL-R) acute lymphoblastic leukemia (ALL) randomized to treatment with a modified P9407 chemotherapy backbone with or without the FLT3 inhibitor lestaurtinib. Secondary 1. To dete ...More

AALL07P1: A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND #58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

  • Conditions: Cancer - Leukemia and Lymphoma
  • Gender: Female, Male

This phase II trial is studying the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. ...More

AALL1121: A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

  • Conditions: Cancer - Leukemia and Lymphoma
  • Gender: Female, Male

The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) and to assess whether this dose of blinatumomab is effective.   ...More

AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

  • Conditions: Cancer - Leukemia and Lymphoma, Leukemia ALL New Diagnosis, Lymphoma Non Hodgkin New Diagnosis

PURPOSE: This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of ...More

AALL1331: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND# 117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

  • Conditions: Cancer - Leukemia and Lymphoma, Leukemia ALL Relapse

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer ...More

AALL1521: A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia

  • Conditions: Cancer - Leukemia and Lymphoma, Leukemia ALL New Diagnosis

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will eval ...More

AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

  • Conditions: Cancer - Leukemia and Lymphoma, Leukemia ALL Relapse

PURPOSE: This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and ma ...More

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Adult Participants or Parents of Participants:

Cincinnati Children’s is involved in research because it is very important to understanding diseases and developing ways to prevent and treat health problems in children, as well as adults. Learn more about how you can help. Contact us at clinicalstudies@cchmc.org or 513-636-0098. Or, enroll in our database to be notified about future studies by completing an online sign up form.

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The Office for Clinical and Translational Research at Cincinnati Children’s provides sponsors and investigators with comprehensive support services, research tools, personnel and facilities to conduct or facilitate pediatric and adult clinical research studies. Contact us at OCTR@cchmc.org or 513-636-0314.