NCT02049580

Brief Summary

Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis lymphomas.

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
47

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

January 28, 2014

Last Update Submit

January 29, 2014

Conditions

Lymphoma

Keywords

lymphoma

Outcome Measures

Primary Outcomes (1)

  • Procedure activity

    1-year Progression Free Survival (PFS) to evaluate the activity of the procedure (taking into account an excess of toxicity). It is assumed that at 1-year a proportion of patients progression free of 20% or lower will be considered to be clinically unworthy, whereas a proportion of 40% or higher will be assumed to be of potential interest.

    1 year

Secondary Outcomes (8)

  • Neutrophils recovery

    1 year

  • Platelets recovery

    1 year

  • Incidence of graft failure

    1 year

  • Cumulative incidence of acute and chronic GVHD

    1 year

  • Incidence of infections

    1 year

  • +3 more secondary outcomes

Study Arms (1)

RIC regimen

EXPERIMENTAL

Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation.

Drug: ThiotepaDrug: FludarabineDrug: Cyclophosphamide

Interventions

ThiotepaDRUG

Thiotepa (10 mg/kg /day) will be administered every 12 h, at day -6

Also known as: Tepadina
RIC regimen
FludarabineDRUG

Fludarabine (30mg/m2/day x 4 days) will be dosed according to renal function. For decreased creatinine clearance (CCr) (≤ 61 mL/min) Fludarabine dosage should be reduced as follows: CCr 46-60 mL/min, fludarabine = 24 mg/ m2/day

Also known as: Fludara
RIC regimen
CyclophosphamideDRUG

Pre-transplantation Cyclophosphamide(Cy) 30 mg/kg/day will be administered as a 1-2 hour intravenous infusion with a high volume fluid flush on Days -5. Cy will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the Adjusted IBW (AIBW) Cyclophosphamide \[50 mg/kg/day IBW\] will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume).

Also known as: Endoxan
RIC regimen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Presence of HLA-matched, related donor (HLA-A, -B, -DRB1)
  • Presence of matched unrelated donor (10/10), available on time.
  • Pregnancy or breast-feeding.
  • Evidence of HIV infection or known HIV positive serology.
  • Current uncontrolled bacterial, viral or fungal infection
  • Evidence of progression of clinical symptoms or radiologic findings.
  • Prior allogeneic hematopoietic stem cell transplant.
  • Central Nervous System (CNS) lymphoma localization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

Related Publications (1)

  • Roberto A, Castagna L, Zanon V, Bramanti S, Crocchiolo R, McLaren JE, Gandolfi S, Tentorio P, Sarina B, Timofeeva I, Santoro A, Carlo-Stella C, Bruno B, Carniti C, Corradini P, Gostick E, Ladell K, Price DA, Roederer M, Mavilio D, Lugli E. Role of naive-derived T memory stem cells in T-cell reconstitution following allogeneic transplantation. Blood. 2015 Apr 30;125(18):2855-64. doi: 10.1182/blood-2014-11-608406. Epub 2015 Mar 5.

    PMID: 25742699DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Thiotepafludarabinefludarabine phosphateCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Luca Castagna, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Castagna, MD

CONTACT

+39028224luca.castagna@humanitas.it

Study Design

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

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

July 1, 2013

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

IT(1)