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Acute Graft Versus Host Disease

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Chronic Myeloproliferative Disorders

HSC835

Novartis Pharmaceuticals

This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies

The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.

Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC \> 0.5 x 109/L which occurred for all patients before 42 days post transplant.

Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement.

Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit

Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year

Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year

Number of participants with Incidence of relapse within one year

Number of participants with Overall survival (OS) within one year

Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause)

Single umbilical cord blood transplant(SUCBT) less than 18 yrs

SUCBT < 18 Yrs

Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs

SUCBT >= 18 Yrs

Double umbilical cord blood transplant (DUCBT) less than 18 yrs

DUCBT < 18 Yrs

Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs

DUCBT >= 18 Yrs

Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT\<18 yrs and SUCBT \>= 18 yrs

SUCBT

Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT\<18 yrs and DUCBT \>= 18 yrs

DUCBT

Total

Age, Continuous

Sex: Female, Male

Study Director

Infusional Toxicity 48 hrs after transplant

Absence of graft failure after 32 days

Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.

Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.

Incidence of Neutrophil Recovery Within 42 Days

Incidence of Platelet Recovery Within Six Months

Predominance of HSC835

Mixed dominance

Predominance of the unmaninpulated unit

Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)

Day 100

Month 12

Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year

aGVHD-Day 100

cGVHD-Month12

Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year

Incidence of Relapse Within One Year

Overall Survival (OS) Within One Year

Disease Free Survival (DFS) Within One Year

Overall Study

Lymphoma, Large B-Cell, Diffuse

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Single arm, pembrolizumab 200mg IV every 3 weeks until progression/toxicity

Stephen Schuster, MD

Single center, phase I/II trial of pembrolizumab after CTL019 for CD19+ lymphomas. Patients will have CD19+ diffuse large B-cell, follicular, or mantle cell lymphomas relapsed/refractory after CTL019. 12 total patients will be enrolled. Safety of pembrolizumab (primary endpoint) will be determined using a Bayesian monitoring rule for treatment-related adverse events causing drug discontinuation. Secondary efficacy endpoints include overall response rate and progression-free survival.

Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas

Phase I/II Study of Pembrolizumab in Patients Failing to Respond to or Relapsing After Anti-CD19 Chimeric Antigen Receptor Modified T Cell Therapy for Relapsed or Refractory CD19+ Lymphomas

Percentage of subjects who discontinued therapy due to dose-limiting toxicity

Abramson Cancer Center at Penn Medicine

Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.

Single Arm

Age, Categorical

Race (NIH/OMB)

United States

Region of Enrollment

Ellen Napier, Nurse Pracitioner

Dose-limiting Toxicity

Overall Response Rates

Disease Progression

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Bendamustine Hydrochloride

Rituximab

Vincristine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w

Comparison of Bendamustine + Rituximab with CHOP + Rituximab

Bendamustine

Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy

Standard chemotherapy CHOP + Ritiximab

Mathias Rummel, Dr.

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

University of Giessen

Study Group indolent Lymphomas (StiL)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies	NCT01474681	Acute Myelocyti... Acute Lymphocyt... Chronic Myeloge... Myelodysplastic... Chronic Lymphoc... Marginal Zone L... Follicular Lymp... Large-cell Lymp... Lymphoblastic L... Burkitt's Lymph... High Grade Lymp... Mantle-cell Lym... Lymphoplasmacyt...	HSC835	10 Years - 55 Years	Novartis
Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas	NCT02650999	CD19+ Diffuse L... Follicular Lymp... Mantle Cell Lym...	Pembrolizumab	18 Years -	Abramson Cancer Center at Penn Medicine
Bendamustine Plus Rituximab Versus CHOP Plus Rituximab	NCT00991211	Non-Hodgkin Lym... Follicular Lymp... Immunocytomas Lymphocytic Lym... Marginal Zone L...	Bendamustine Standard chemot...	18 Years -	University of Giessen
Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas	NCT02650999	CD19+ Diffuse L... Follicular Lymp... Mantle Cell Lym...	Pembrolizumab	18 Years -	Abramson Cancer Center at Penn Medicine

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