Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Hematologic Neoplasms

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression, development of other unacceptable toxicity or Investigator discretion

AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression or development of other unacceptable toxicity

AG881

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation

The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-881 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs or the patient is removed at the discretion of the investigator.

Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation

Agios Pharmaceuticals, Inc.

Immune System Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Tipifarnib

Bridget Martell, MD

Phase II study designed to investigate antitumor activity in terms of objective response rate (ORR) of tipifarnib subjects with advanced Peripheral T-Cell Lymphoma (PTCL). Tipifarnib will be administered orally until disease progression.

This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with relapsed or refractory PTCL. The first 18 subjects may be of the following PTCL sub-types: PTCL not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), ALK-positive and negative anaplastic large cell lymphoma (ALCL), hepatosplenic T-cell lymphoma, enteropathy-associate T-cell lymphoma (EATL), extranodal natural killer (NK) T-cell lymphoma, nasal type and subcutaneous panniculitis-like T-cell lymphoma. The AITL expansion cohort (N=32) will enroll only subjects with AITL. An additional cohort of patients (N=12) expressing the wild type CXCL12 3' UTR will be enrolled in order to explore the benefits of tipifarnib treatment observed in patients having an absence of this gene variation or single nucleotide variation (SNV).

Tumor response assessments will be conducted according to Lugano Classification and/or mSWAT criteria.

Tumor assessments will be performed approximately every 8 weeks (cycles 2-6) and at least once approximately every 12 weeks thereafter (Cycles 9, 12, 15, etc.), and will continue until disease progression. Subjects experiencing a complete response may be considered for bone marrow transplantation. Upon disease progression, all subjects will be followed for survival and the use of subsequent therapy. All subjects will be followed for safety during treatment and up to approximately 30 days after treatment discontinuation or until before the initiation of another anti-cancer therapy. Additional follow up may be implemented until the subject recovers from any emergent treatment related toxicity or the adverse event is considered irreversible by the investigator.

Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.

An Open Label Phase II Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma

Response assessments according to Lugano Classification and/or mSWAT

To determine the antitumor activity in terms of PFS in subjects with relapsed/refractory PTCL

To determine the antitumor activity in terms of DOR in subjects with relapsed/refractory PTCL

To evaluate the safety and tolerability of tipifarnib in subjects with relapsed/refractory PTCL

Kura Oncology, Inc.

Antibodies

Antibodies, Bispecific

Immunoglobulins

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed

ONO-4685

Ono Pharma USA, Inc.

Project Leader

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma

Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.

MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

Plasma concentration will be assessed to evaluate Pharmacokinetics

ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.

Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.

Ono Pharmaceutical Co. Ltd

Immunoblastic Lymphadenopathy

Lymphoma, Large-Cell, Anaplastic

Lymphadenopathy

Angioimmunoblastic T-cell Lymphoma

Angioimmunoblastic Lymphadenopathy With Dysproteinemia

Anaplastic Large Cell Lymphoma

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Etoposide phosphate

Romidepsin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Histone Deacetylase Inhibitors

Tubulin Modulators

Antimitotic Agents

During the Phase I It will administered Romidepsin (dose escalation) and the combination of CHOEP-21. During the Phase II It will administered Romidepsin (dose according to phase I) and the combination of CHOEP-21.

Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8

Dose modification according to toxicity:

* 14mg/ms day +1 and +8
* 10mg/ms day +1 and +8
* 8mg/ms day +1 and +8

CHOEP-21

* Doxorubicin 50 mg/ms iv day +1 or +2,
* Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2
* Cyclophosphamide 750 mg/ms iv day +1 or +2
* Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4
* Prednisone100 mg orally from days +1 to +5 or from days +2 to +6

PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)

Ro-CHOEP-21 (PHASE I)

Ro-CHOEP-21 x 3 cycles

* Romidepsin dose according to phase I iv day +1 and +8
* Doxorubicin 50 mg/ms iv day +1 or +2,
* Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2,
* Cyclophosphamide 750 mg/ms iv day +1 or +2
* Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4
* Prednisone100 mg orally from days +1 to +5 or from days +2 to +6

PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)

Ro-CHOEP-21 (PHASE II)

Paolo Corradini, Prof

This is a multicenter study that includes two phases:

1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study.
2. A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT.

PHASE I A1) Induction phase Ro-CHOEP-21 x 3 cycles

* Romidepsin (dose escalation) starting dose: 12mg/ms iv day +1 and +8. Dose modification according to toxicity (14mg/ms day +1 and +8; 10mg/ms day +1 and +8; 8mg/ms day +1 and +8);
* CHOEP-21 (Doxorubicin 50 mg/ms iv day +1; Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1; Cyclophosphamide 750 mg/ms iv day +1; Etoposide 100mg/ms iv from day +1 to +3; Prednisone100 mg orally from days +1 to +5).

According to the response achieved after the first 3 Ro-CHOEP-21 cycles:

* PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by phase A2
* SD or PD: Treatment failures, proceed to salvage according to each institutional policy.

A2) Stem cell mobilization and transplantation phase Response evaluation and one DHAP course followed by peripheral stem cell harvesting.

According to response achieved after 6 Ro-CHOEP-21 cycles:

CR: BEAM or FEAM or CEAM followed by auto-SCT PR

* Allogeneic SCT with HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors. Donor selection is based on molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA-A, B, and C) and class II (DRB1, DQB1). In case, no class I and class II completely identical urelated donor (10 out of 10 gene loci) can be identified, the degree of histocompatibility between patient and donor must fulfill with the minimal degree of matching established by the Italian Bone Marrow Donor Registry: HLA-A and HLA-B antigen histocompatibility and HLA-DRB1 allelic histocompatibility.
* when a suitable donor is not available: BEAM or FEAM or CEAM followed by Auto-SCT.
* Haploidentical transplantation is allowed in selected cases \< PR: Treatment failures, proceed to salvage according to each institutional policy.

PHASE II A1) Induction phase Ro-CHOEP-21 x 3 cycles

* Romidepsin dose according to phase I iv day +1 and +8
* Doxorubicin 50 mg/ms iv day +1,
* Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1,
* Cyclophosphamide 750 mg/ms iv day +1,
* Etoposide 100mg/ms iv from day +1 to +3
* Prednisone100 mg orally from days +1 to +5

According to the response achieved after the first 3 Ro-CHOEP-21 cycles:

* PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by phase A2
* SD or PD: Treatment failures, proceed to salvage according to each institutional policy.

A2) Stem cell mobilization and transplantation phase Response evaluation and one DHAP course followed by peripheral stem cell harvesting.

According to response achieved after 6 Ro-CHOEP-21 cycles:

CR: BEAM or FEAM or CEAM followed by auto-SCT PR

* Allogeneic SCT with HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors. Donor selection is based on molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA-A, B, and C) and class II (DRB1, DQB1). In case, no class I and class II completely identical urelated donor (10 out of 10 gene loci) can be identified, the degree of histocompatibility between patient and donor must fulfill with the minimal degree of matching established by the Italian Bone Marrow Donor Registry: HLA-A and HLA-B antigen histocompatibility and HLA-DRB1 allelic histocompatibility.
* when a suitable donor is not available: BEAM or FEAM or CEAM followed by Auto-SCT.
* Haploidentical transplantation is allowed in selected cases \< PR: Treatment failures, proceed to salvage according to each institutional policy.

Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas

Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study

Evaluation of response biomarkers (eg TET2 mutations)

Incidence of dose-limiting toxicity (DLT) of Ro-CHOEP-21, considering as maximum dose the one causing induction of any grade ≥ 3 non hematologic toxicity or a delay \>15 days of planned cycle date observed during the first two cycles according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)

PFS on intention to treatment (ITT) evaluated at 18 months. PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.

Overall response rate (ORR, defined according to the Cheson 2007 response criteria) of the combination of Ro-CHOEP-21.

ORR and CR (defined according to the Cheson 2007 response criteria), after induction treatment and after SCT.

Event free survival (EFS) defined as the time between the date of enrollment and the date of discontinuation of treatment for any reason

Overall survival (OS) defined as the time between the date of enrolment and the date of death from any cause in the ITT population enrolled in the study

PFS and OS in patients not responding to the first 3 courses of Ro-CHOEP-21

Evaluation during the interim analyses of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)

Evaluation during all the pretransplant phase of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)

Treatment-related mortality defined as any death that was not attributable to the lymphoma.

Incidence of acute and chronic GVHD in allografted patients

Fondazione Italiana Linfomi - ETS

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Lenalidomide

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle

Li Wang, M.D., Ph.D.

Wei Xu, M.D., Ph.D.

Li Wang, M.D., Ph.D

Wei Xu, M.D., Ph.D

The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.

Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

overall response rate after treated by lenalidomide-CHOP regimen

from date of inclusion to date of progression, relapse, or death from any cause

from the date of inclusion to date of death, irrespective of cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation	NCT02492737	Acute Myeloid L... Myelodysplastic... Hematologic Mal...	AG881	18 Years -	Agios Pharmaceuticals, Inc.
Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.	NCT02464228	Relapsed or Ref...	Tipifarnib	18 Years -	Kura Oncology, Inc.
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma	NCT05079282	Relapsed or Ref...	ONO-4685	18 Years -	Ono Pharmaceutical Co. Ltd
Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas	NCT02223208	Peripheral T-ce... PTCL-NOS Angioimmunoblas... ALK- Anaplastic... Nodal Periphera...	Ro-CHOEP-21 (PH... Ro-CHOEP-21 (PH...	18 Years - 65 Years	Fondazione Italiana Linfomi - ETS
Lenalidomide in Combination With CHOP in Patients With Untreated PTCL	NCT04423926	PTCL, NOS AITL ALK- ALCL Phase III-IV AL... EATL	Lenalidomide Cyclophosphamid... Doxorubicin Vincristine Prednisolone	18 Years - 70 Years	The First Affiliated Hospital with Nanjing Medical University
Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation	NCT02492737	Acute Myeloid L... Myelodysplastic... Hematologic Mal...	AG881	18 Years -	Agios Pharmaceuticals, Inc.
Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.	NCT02464228	Relapsed or Ref...	Tipifarnib	18 Years -	Kura Oncology, Inc.

Spots Global Cancer Trial Database for aitl

Every month we try and update this database with for aitl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aitl

Every month we try and update this database with for aitl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aitl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.