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CD34+ Transplants for Leukemia and Lymphoma

ConditionsLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Acute
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorGuenther Koehne

About this trial

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).

Secondary AML in 1st remission

AML in 1st relapse or 2nd remission

ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission

Disqualifiers

Female patients who are pregnant or breast-feeding

Active viral, bacterial or fungal infection

Patient seropositive for HIV-I /II; HTLV -I /II

Presence of leukemia in the CNS

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total Body Irradiation (TBI)

    Radiation

    Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.

  • Thiotepa

    Drug

    Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).

  • Cyclophosphamide

    Drug

    Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated

  • Busulfan

    Drug

    Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics

  • Melphalan

    Drug

    Melphalan: 70 mg/m\^2/day x 2

  • Fludarabine

    Drug

    Fludarabine: 25 mg/m\^2/day x 5

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Regimen A: TBI/Thiotepa/CyclophosphamideExperimental treatment 3 interventions
Group B: Regimen B: Busulfan/Melphalan/FludarabineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence rate of graft versus host disease (GvHD)

Incidence of acute and chronic GvHD

Time frame
Two years
2

Severity of disease

Severity of the adverse events will be reported based on the CTCAE Version 5.

Time frame
Two years
3

Incidence of transplant-related mortality (TRM)

TRM includes fatal complications resulting from the allogeneic transplant and/ or treatment regimens such as graft failure, GvHD, hemorrhages, and infections.

Time frame
Two years
4

Change in overall survival (OS)

OS is defined as time from transplant to death or last follow-up.

Time frame
Six months, one year, two years

Secondary outcomes

1

Proportion of patients optimal and suboptimal doses

The proportion of patients receiving optimal cell doses (CD34+: \>5x 10\^6/kg and CD3+: \< 5 x10\^4/kg) and suboptimal doses (CD34+: \<3 x 10\^6/kg and CD3+: \>5 x 10\^4/kg).

Time frame
Two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guenther Koehne

Lead sponsor

Baptist Health South Florida

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: