NCT02507479

Brief Summary

The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2015

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

June 14, 2015

Last Update Submit

April 19, 2016

Conditions

Non Hodgkin LymphomaHodgkin LymphomaChronic Lymphocytic LeukemiaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    The percentage of patients alive without disease recurrence 2 years after transplant

    2 years after transplantation

Secondary Outcomes (3)

  • treatment-related mortality

    2 years after transplantation

  • graft versus host disease

    1 year after transplantation

  • relapse

    2 years after transplantation

Study Arms (1)

thiotepa

EXPERIMENTAL

Thiotepa 5-10 mg/kg/d x 2 days

Drug: Thiotepa

Interventions

ThiotepaDRUG

Chemotherapy given prior to allogeneic stem cell transplantation

thiotepa

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age less than physiologic 68 years.
  • Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
  • MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
  • Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
  • Follicular lymphoma; failure of at least one prior regimen
  • CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
  • Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient
  • Patients must sign written informed consent.
  • Adequate birth control in fertile patients.

You may not qualify if:

  • Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
  • Creatinine \> 2.0 mg/dl
  • ECOG-Performance status \> 2
  • Uncontrolled infection
  • Pregnancy or lactation
  • Abnormal lung diffusion capacity (DLCO \< 40% predicted)
  • Severe cardiovascular disease
  • CNS disease involvement
  • Pleural effusion or ascites \> 1 liter
  • Known hypersensitivity to Fludarabine or treosulfan
  • Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Chaim Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseaseLeukemia, Lymphocytic, Chronic, B-CellMultiple Myeloma

Interventions

Thiotepa

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

PhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Arnon Nagler, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Avichai Shimoni, MD

CONTACT

972 3 530 5830ashimoni@sheba.health.gov.il

Arnon Nagler, MD

CONTACT

9972 3 530 5830a.nagler@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2015

First Posted

July 24, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2019

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IL(2)